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angiotensin receptor blockers (ARBs) (n=58) vs. placebo (n=59)
randomized controlled trial
Losartan
Losartan 25 mg orally twice daily unless estimated glomerular filtration rate, eGFR, was reduced, when dosing was reduced to once daily.
Placebo
COVID 19 outpatients
presumptive positive laboratory test for SARS-coV-2 or upper respiratory infection with recent exposure to laboratory-proven SARS-coV-2-infected personnegative influenza and respiratory virus panel
Double-blind.
3 hospitals in Minnesota, United States.
azithromycin (n=171) vs. placebo (n=92)
randomized controlled trial
azithromycin
oral azithromycin : a single 1.2g dose PO
placebo
COVID 19 outpatients
patients must be able to return internet-based study questionnaires
Double blind.
Across the United States.
azithromycin (n=540) vs. standard of care (n=875)
randomized controlled trial
azithromycin 500 mg daily for three days plus usual care
usual care alone
3 arms: usual care plus azithromycin 500 mg daily for three days, usual care plus other interventions, or usual care alone
COVID 19 outpatients
open-label
nationwide, UK
azithromycin (n=147) vs. standard of care (n=148)
randomized controlled trial
azithromycin
500 mg once daily for 14 days
standard of care
COVID 19 outpatients
open label
19 centers, UK
800 patients anticipated 298 included, primary outcome was updated after the pre-planned interim analysis and sample size was adapted
azithromycin plus hydroxychloroquine (n=42) vs. placebo (n=42)
randomized controlled trial
Hydroxychloroquine plus azithromycin
200 mg HCQ capsules twice a day for a total course of seven days and one 500 mg AZT capsule taken on day 1, followed by one 250 mg AZT capsule daily for the next four days (i.e. 6 capsules in total).
Placebo
The placebo capsules were formulated to have similar size, shape, color and taste as hydroxychloroquine and azithromycin capsules, and with an identical dosing regimen.
COVID 19 outpatients
Age between 18 and 65 years, Flu-like symptoms beginning 2-5 days prior, Infection by SARS-CoV-2, Not requiring hospital admittance, Consenting to study participation.
Double-blind.
Single center: Hospital Santa Paula, Sao Paulo, Brazil.
azithromycin plus hydroxychloroquine (n=152) vs. placebo (n=152)
randomized controlled trial
Hydroxychloroquine plus azithromycin
HCQ : 600 mg daily for one weekAZI : 500 mg day one,250 mg daily on days two through five
placebo
3 arms: Hydroxychloroquine plus azithromycin, hydroxychloroquine monotherapy, and placebo (1:1:1 ratio)
COVID 19 outpatients
Double-blind.
Multicenter: 2 centres in Doha, Qatar.
bamlanivimab monotherapy (n=101) vs. placebo (n=156)
randomized controlled trial
Bamlanivimab (LY-CoV555) 700 mg
placebo
5 arms: placebo, bamlanivimab 700 mg, 2800 mg, and 7000 mg and 2800 mg of bamlanivimab and 2800 mg of etesevimab
COVID 19 outpatients
double-blind
Phase 2: exploratory trial, originally designed as a safety and biomarker study. Inconclusive for the primary endpoint.
As of April 2021, regulatory authorities recommend that bamlanivumab no longer be used because of the potential risk of treatment failure due to the circulation of resistant variants of SARS-CoV-2.
bamlanivimab/etesevimab (n=112) vs. placebo (n=156)
randomized controlled trial
bamlanivimab 2800 mg and etesevimab 2800 mg
placebo
5 arms: placebo, bamlanivimab 700 mg, 2800 mg, and 7000 mg and 2800 mg of bamlanivimab and 2800 mg of etesevimab
COVID 19 outpatients
double-blind
Phase 2. Exploratory trial, originally designed as a safety and biomarker study.
October, 2021 EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly. Janvier, 2022: FDA limit the use of bamlanivimab and etesevimab to infection due to susceptible variants (ie not omicron).
bamlanivimab/etesevimab (n=518) vs. placebo (n=517)
randomized controlled trial
bamlanivimab 2,800 mg plus etesevimab 2,800 mg
single intravenous (IV) infusion within 3 days of having a positive result on a SARS-CoV-2 virologic test
placebo
COVID 19 outpatients
Participants were excluded if they had a saturation of oxygen (SpO2) ≤93% on room air, respiratory rate ≥30 breaths/min, or heart rate ≥125 bpm
double-blind
October, 2021 EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly. Janvier, 2022: FDA limit the use of bamlanivimab and etesevimab to infection due to susceptible variants (ie not omicron).
budesonide (n=1073) vs. standard of care (n=1988)
randomized controlled trial
inhaled budesonide (800μg twice daily for 14 days) plus usual care
Inhaled budesonide (800μg twice daily for 14 days) plus usual care;
usual care
several arms: usual care, usual care plus budesonide or usual care plus other interventions
COVID 19 outpatients
Open-label.
United Kingdom.
casirivimab/imdevimab (Ronapreve) (n=838) vs. placebo (n=840)
randomized controlled trial
REGEN-CO 1200mg (casirivimab and imdevimab) IV
Placebo
3 arms: placebo, REGEN-COV 2400mg (1200mg each antibody) and REGEN-COV 1200mg (600mg each antibody). (8,000 mg data were converted to a descriptive analysis)
COVID 19 outpatients
Patients ≥18 years of age and non-hospitalized, with a confirmed local SARS-CoV-2-positive diagnostic test result ≤72 hours and onset of any Covid-19 symptom, as determined by the investigator, ≤7 days before randomization, maintain O2 saturation ≥93% breathing room air, not have prior or current use of putative COVID-19 treatments (e.g. convalescent plasma, systemic corticosteroids or remdesivir) and not have been previously or currently hospitalized for treatment of COVID-19.
Double-blind.
Analysis in modified full analysis set (subjects with positive RT-qPCR test at baseline).The primary and two key secondary endpoints were tested hierarchically. The key secondary clinical endpoints were (1) the proportion of patients with ≥1 Covid-19-related hospitalization or all-cause death from day 4 through day 29 and (2) the time to Covid-19 symptoms resolution (19 of the 23 recorded symptoms).
*Warning! The spread of new Sars-Cov2 variants is constantly evolving, this study was performed in a different viral context than today, its results should be interpreted accordingly.*
casirivimab/imdevimab (Ronapreve) (n=156) vs. placebo (n=158)
randomized controlled trial
Casirivimab 600 mg and imdevimab 600 mg
Single 1200 mg dose.
Placebo
Placebo at day 1 via subcutaneous injection.
COVID 19 outpatients
Double-blind.
112 sites in the US, Romania and Moldova.
The trial consists of a 1-day screening/baseline period, a 28-day efficacy assessment period (EAP), and a 7-month follow-up period.
*Warning! The spread of new Sars-Cov2 variants is constantly evolving, this study was performed in a different viral context than today, its results should be interpreted accordingly.*
ciclesonide (n=197) vs. placebo (n=203)
randomized controlled trial
Ciclesonide pressurised metered-dose inhaler (pMDI).
Supportive care plus ciclesonide (Alversco) 320 mcg twice daily for 30 days via pMDI.
Placebo
Supportive care plus placebo mztching Alvesco, twice daily for 30 days via pMDI.
Standard supportive care was provided at the discretion of the study nurse or physician and included recommendations for symptomatic medications and directions to seek emergency care when necessary.
COVID 19 outpatients
Double-blind.
Multicenter; 10 centers throughout the US (public and private, academic and non-academic sites).
Time to alleviation of COVID-19-related symptoms of cough, dyspnea, chills, feeling feverish, repeated shaking with chills, muscle pain, headache, sore throat, and new loss of taste or smell, defined as symptom-free for a continuous period of more than 24 hours (ie, later than 3 AM/PM assessments) by day 30.
Changes in primary outcome during the trial: A primary outcome based on symptom resolution was chosen rather than one based on emergency department visits or hospital admission after preliminary data demonstrated substantially lower than expected rates of emergency department visits or hospitalizations among study participants.
ciclesonide (n=108) vs. placebo (n=107)
randomized controlled trial
Ciclesonide
Inhaled ciclesonide (600 μg twice daily) along with the usual dose of intranasal ciclesonide (200 μg daily) for 14 days.
Placebo
Saline placebo metered dose inhaler and intranasal saline of a similar appearance to ciclesonide at the same dosing schedule.
COVID 19 outpatients
Adults aged 18 years and older who had polymerase chain reaction confirmed COVID-19 at enrolment with at least one of the symptoms of fever, cough (wet or dry), or shortness of breath (including dyspnoea, chest congestion, or chest tightness as synonyms). People were excluded if they were admitted to hospital, had only non-respiratory symptoms (eg, nasal congestion, myalgias, or gastrointestinal symptoms), had already been prescribed an inhaled steroid.
Double-blind.
Three Canadian provinces (Quebec, Ontario, and British Columbia).
Enrolment to the trial began on 15 September 2020 in Quebec, 9 February 2021 in Ontario, and 22 March 2021 in British Columbia. The last participants were recruited on 8 June 2021. Participants self-reported outcome data for the 14 days after enrolment, including improvement in covid-19 related respiratory symptoms, other covid-19 symptoms, adherence to the trial intervention, side effects, and hospital admissions.
colchicine (n=2235) vs. placebo (n=2253)
randomized controlled trial
Colchicine
Colchicine 0.5 mg per os twice daily for the first 3 days, then once daily for the last 27 days.
Placebo
Placebo per os twice daily for the first 3 days, then once daily for the last 27 days.
COVID 19 outpatients
adults >= 40 years old diagnosed with COVID19 within the last 24h; not currently hospitalized and not under immediate consideration for hospitalization. Patients must possess at least one high-risk criteria (>70 years old, diabetes mellitus, uncontrolled hypertension, respiratory disease, heart failure, coronary disease, fever of ≥38.4°C within the last 48 hours, dyspnea at the time of presentation, bicytopenia, pancytopenia, or the combination of high neutrophil count and low lymphocyte count).
Double blind, randomized.
Brazil, Canada, Greece, South Africa, Spain, and the USA
multiple testing
premature discontinuation due to logistical issues
colchicine (n=212) vs. standard of care (n=2081)
randomized controlled trial
Colchicine
Usual care plus colchicine 500µg daily for 14 days.
Usual care
COVID 19 outpatients
Open-label.
Participants were followed up through an online, daily symptom diary for 28 days after randomisation, supplemented with telephone calls to non-responders on days 7, 14 and 28. The diary includes questions about illness recovery (ascertained by answering the question, “Do you feel recovered today? (i.e. symptoms associated with illness are no longer a problem) Yes/No”), overall illness severity (a rating of how well they are feeling on a scale of 1-10 [1 being the worst and 10 being the best]), individual symptom severity on a four-point scale (0 = no problem to 3 =major problem), and healthcare service utilisation.
Trial stopped for futility on May 26, 2021.
convalescent plasma treatment (n=257) vs. placebo (n=254)
randomized controlled trial
COVID-19 convalescent plasma
One unit (250 mL) of ABO-compatible COVID-19 convalescent plasma.
Placebo
250 mL of normal saline (colored with a parenteral multivitamin concentrate to resemble plasma).
COVID 19 outpatients
=< 18 years with one or more symptoms of COVID-19 illness and laboratory-confirmed SARS-Cov-2 infection, at least one study defined risk factor for severe COVID-19 illness, clinical team deems stable for outpatient management without supplemental oxygen, CP available at the site at the time of enrollment, duration of symptoms =< 7 days at ED presentation, informed consent from subject.
Single-blind.
Multicenter: 48 hospital emergency departments across the United States.
Trial enrollment was halted after the second planned interim analysis of the primary outcome indicated that the a priori stopping threshold for futility had been reached on the basis of a posterior predictive probability of success of 0.042.
convalescent plasma treatment (n=188) vs. placebo (n=160)
randomized controlled trial
convalescent plasma
anti-SARS-CoV-2 MBT plasma plus SMT will undergo an ABO compatibility test and will receive a single infusion of 200 to 300 ml
placebo
200 to 300ml of sterile saline solution 0.9%.
COVID 19 outpatients
double blind
4 centers, Spain
The trial was stopped early following a data safety monitoring board recommendation because more than 85% of the target population had received a COVID-19 vaccin
convalescent plasma treatment (n=207) vs. placebo (n=209)
randomized controlled trial
convalescent plasma
placebo
regular plasma
COVID 19 outpatients
double blind
netherlands
phase 3. Based on the recommendation by the DSMB (rapid uptake of vaccination and effective monoclonal antibodies available for high risk outpatients), the study was terminated on the 13th of July 2021 before the planned sample size of 690 was reached
discontinuation of ACEI/ARB (n=104) vs. continuation of ACEI/ARB (n=100)
randomized controlled trial
discontinuation of RAS inhibition
continuation of RAS inhibition
COVID 19 outpatients
open-label
35 centres in Austria and Germany
fluvoxamine (n=334) vs. placebo (n=327)
randomized controlled trial
fluvoxamine at a dose of 50 mg twice daily for 14 days
placebo
COVID 19 outpatients
double-blind
US, 6 centres
2-by-3 factorial design (metformin, ivermectin, and fluvoxamine)
fluvoxamine (n=741) vs. placebo (n=756)
randomized controlled trial
Fluvoxamine
100mg twice daily for 10 days.
Placebo
Twice daily for 10 days.
All participants received usual standard care for COVID-19 provided by healthcare professionals workers at public health facilities. Clinicians providing usual care in public health facilities typically focus on the management of symptoms and with antipyretics, and recommend antibiotics only if they suspect bacterial pneumonia.
COVID 19 outpatients
Patients over 18 years old with the ability to provide free and informed consent with Acute Flu-Like symptoms < 07 days and at least ONE enhancement criteria (Age > 50 years; Diabetes mellitus requiring oral medication or insulin Systemic arterial hypertension requiring at least 01 oral medication for BP control; Known cardiovascular diseases (heart failure, congenital heart disease, valvar heart valve disease, coronary artery disease, cardiomyopathies) Symptomatic lung disease (emphysema, chronic bronchitis) Symptomatic asthma patients requiring chronic use of agents for control of symptoms. Fever > 38 C at baseline Obesity, defined as BMI> 30 kg / m2 body weight Transplanted patients Patient with stage IV chronic kidney disease or on dialysis. Immunosuppressed patients/ using corticosteroid therapy (equivalent to maximum 10 mg of prednisone per day) and/ or immunosuppressive therapy) Patients with a history of cancer in the last 05 years or undergoing treatment of a current cancer Chronic renal disease KDIGO IV or End-Stage Renal Disease on chronic ambulatory renal replacement therapy Patients with important limitation of daily activities due to: Dyspnea, chest pain myalgia (limited to 25% of all randomizations) ). Patient with positive rapid test for SARS-CoV2 antigen performed on occasion of the screening or patient with a positive SARS-CoV2 diagnostic test within 07 days of the onset of symptoms.
Double-blind.
10 sites in Minas Gerais, Brazil.
Bayesian analysis.
Some inconsistencies between preprint and publication in terms of population size and inclusion period.
fluvoxamine (n=80) vs. placebo (n=72)
randomized controlled trial
fluvoxamine
100mg 3 times daily for 15 days
placebo
COVID 19 outpatients
double-blind
St Louis metropolitan area (Missouri and Illinois), USA
fluvoxamine (n=674) vs. placebo (n=614)
randomized controlled trial
fluvoxamine
fluvoxamine 50 mg twice daily for 10 days
placebo
COVID 19 outpatients
non-hospitalized adults aged ≥30 years with confirmed COVID-19 experiencing ≥2 symptoms of acute infection for ≤7 days prior to randomization
double-blind
time to sustained recovery was defined as the third of 3 consecutive days without symptoms
hydroxychloroquine (n=244) vs. placebo (n=247)
randomized controlled trial
hydroxychloroquine 600mg
oral hydroxychloroquine, 800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 more days
placebo
COVID 19 outpatients
double-blind
United States and Canada (40 states and 3 provinces)
hydroxychloroquine (n=214) vs. placebo (n=227)
randomized controlled trial
Hydroxychloroquine
Hydroxychloroquine loading dose of 800 mg at the time of randomization and then 400 mg in daily doses at 8:00 AM for 9 days.
Placebo
Corresponding tablets of inert material (talc). Placebo bottles were matched for the same number of tablets as active lopinavir-ritonavir.
3 arms: Hydroxychloroquine, lopinavir-ritonavir or placebo (1:1:1).
COVID 19 outpatients
Patients 18 years or older; reported less than 8 days since onset of flulike symptoms or chest computerized tomography scan consistent with COVID-19 and at least one additional criterion for high risk: aged 50 years or older; presence of pulmonary disease, specifically moderate or severe persistent asthma, chronic obstructive pulmonary disease, pulmonary hypertension, or emphysema; diabetes requiring oralmedication or insulin; hypertension requiring treatment; known cardiovascular diseases (congestive heart failure of any etiology, documented coronary artery disease, clinically manifest miscellaneous heart disease); symptomatic lung disease on chronic treatment; history of transplantation; obesity (body mass index 30 [calculated as weight in kilograms divided by height in meters squared]); immunocompromised status due to disease (eg, those living with HIV with a CD4 T-cell count of <200 cells/mm3, confirmed malignant neoplasm); immunocompromised status due to medication (eg, people taking 10 mg or more of prednisone equivalents a day); and patients with cancer.
Double-blind.
10 cities in Brazil.
The trial was stopped after the interim analysis for futility with a sample size of 685 patients.
hydroxychloroquine (n=689) vs. placebo (n=683)
randomized controlled trial
hydroxychloroquine 400 mg BID in the first day, 400 mg OD thereafter for a total of seven days
placebo
COVID 19 outpatients
double-blind
56 Brazilian sites
hydroxychloroquine (n=137) vs. standard of care (n=157)
randomized controlled trial
hydroxychloroquine 400mg
hydroxychloroquine (800 mg on day 1, followed by 400 mg once daily for 6 days)
standard of care
COVID 19 outpatients
moste patients were healthcare workesr (86.7%)
open-label
Catalonia, Spain
hydroxychloroquine (n=15) vs. standard of care (n=13)
randomized controlled trial
hydroxychloroquine
2x200mg twice a day
placebo
COVID 19 outpatients
double-blind
1 centre, USA
interim analysis. study discontinuated due to rapide decline of infection rate during the study accrual period.
ivermectin (n=602) vs. placebo (n=604)
randomized controlled trial
ivermectin, with a maximum targeted dose of 600 μg/kg for 6 days
placebo
COVID 19 outpatients
double-blind
93 sites in the US
ivermectin (n=250) vs. placebo (n=251)
randomized controlled trial
ivermectin
24 to 48 mg (depends on the weight of the patient) at day 1 and day 2
placebo
COVID 19 outpatients
double-blind
1 center, Argentina
ivermectin (n=12) vs. placebo (n=12)
randomized controlled trial
ivermectin
400 mcg/kg, single dose
placebo
COVID 19 outpatients
double bliind
1 center, Spain
ivermectin (n=679) vs. placebo (n=679)
randomized controlled trial
Ivermectin 400 mcg/kg up to 90kg weight every 24 hours for 3 days
placebo
COVID 19 outpatients
double-blind
12 public health clinics in Brazil
adaptive platform trial
ivermectin (n=817) vs. placebo (n=774)
randomized controlled trial
ivermectin 400 mcg/kg daily for 3 days
placebo
COVID 19 outpatients
non-hospitalized adults age >=30 years with confirmed COVID-19, experiencing 2 or more symptoms of acute infection for <=7 days
double-blind
ivermectin (n=200) vs. placebo (n=200)
randomized controlled trial
Ivermectin
300 µg/kg of body weight per day of oral ivermectin in solution, for 5 days.
Placebo
300 µg/kg of body weight per day of oral placebo for 5 days.
Placebo was a solution with similar organoleptic properties to ivermectin. Bottles of ivermectinand placebo were identical throughout the study period toguarantee double-blinding.
COVID 19 outpatients
Adult subjects over 18 years of age with SARS CoV2 / COVID 19 disease confirmed by antigen detection tests authorized by INVIMA or by RT-PCR in any of the laboratories that report to the Departmental Health Secretary, approved for the diagnosis of COVID-19 by the National Institute of Health. Onset of SARS CoV2 / COVID 19 illness 7 days ago or less, subjects with mild disease, informed consent signature.
Double-blind.
Single site in Cali, Colombia.
ivermectin (n=410) vs. placebo (n=398)
randomized controlled trial
ivermectin at a dose of 390 to 470 μg per kilogram per day for 3 days
placebo
COVID 19 outpatients
double-blind
US, 6 centres
2-by-3 factorial design (metformin, ivermectin, and fluvoxamine)
lopinavir/ritonavir (n=244) vs. placebo (n=227)
randomized controlled trial
Lopinavir-ritonavir
Lopinavir-ritonavir: loading dose of 800 mg and 200 mg, respectively, every 12 hours followed by 400 mg and 100 mg, respectively, every 12 hours for the next 9 days.
Placebo
Corresponding tablets of inert material (talc). Placebo bottles were matched for the same number of tablets as active lopinavir-ritonavir.
3 arms: Hydroxychloroquine, lopinavir-ritonavir or placebo (1:1:1).
COVID 19 outpatients
Patients 18 years or older; reported less than 8 days since onset of flulike symptoms or chest computerized tomography scan consistent with COVID-19 and at least one additional criterion for high risk: aged 50 years or older; presence of pulmonary disease, specifically moderate or severe persistent asthma, chronic obstructive pulmonary disease, pulmonary hypertension, or emphysema; diabetes requiring oralmedication or insulin; hypertension requiring treatment; known cardiovascular diseases (congestive heart failure of any etiology, documented coronary artery disease, clinically manifest miscellaneous heart disease); symptomatic lung disease on chronic treatment; history of transplantation; obesity (body mass index 30 [calculated as weight in kilograms divided by height in meters squared]); immunocompromised status due to disease (eg, those living with HIV with a CD4 T-cell count of <200 cells/mm3, confirmed malignant neoplasm); immunocompromised status due to medication (eg, people taking 10 mg or more of prednisone equivalents a day); and patients with cancer.
Double-blind.
10 cities in Brazil.
The trial was stopped after the interim analysis for futility with a sample size of 685 patients.
metformin (n=663) vs. placebo (n=660)
randomized controlled trial
immediate-release metformin administered with an increase in dose over 6 days to 1500 mg per day for 14 days,
placebo
COVID 19 outpatients
double-blind
US, 6 centres
2-by-3 factorial design (metformin, ivermectin, and fluvoxamine)
molnupiravir (n=716) vs. placebo (n=717)
randomized controlled trial
Molnupiravir (Lagevrio)
800 mg of Molnupiravir orally twice daily for 5 days.
Placebo
Placebo orally twice daily for 5 days.
COVID 19 outpatients
Patients with laboratory-confirmed mild-to-moderate COVID-19, with symptom onset within 5 days of study randomization. Eligible subjects were 18 years of age and older and had one or more pre-defined risk factors for disease progression: 60 years of age or older, diabetes, obesity (BMI >30), chronic kidney disease, serious heart conditions, chronic obstructive pulmonary disease, or active cancer. The study included symptomatic subjects not vaccinated against SARS-CoV-2 and who had laboratory confirmed SARS-CoV-2 infection and symptom onset within 5 days of enrolment.
Double-blind.
170 sites in 23 countries: Argentina, Brazil, Canada, Chile, Colombia, Egypt, France, Germany...
Planned interim analysis to assess efficacy/futility based on 50% of the planned phase 3 enrollment (775/1550) with an alpha spending function that controlled the type I error rate at alpha = 0.025 (one sided) with a criterion to declare early efficacy of p<0.0092. Missing mortality status at day 29 was imputed as hospitalization or death.
Trial stopped early for efficacy at the planned interim analysis. The formal evaluation of efficacy is considered complete at the planned interim analysis at which time the statistical criterion for success was met. The analyses of data for the full population are considered supportive analyses.
molnupiravir (n=140) vs. placebo (n=62)
randomized controlled trial
Molnupiravir
Molnupiravir 200mg, 400mg or 800mg administered orally twice daily for 5 days.
Placebo
Twice daily for 5 days, orally.
COVID 19 outpatients
Double-blind.
Multicenter; 10 sites in the USA.
Phase 2a.
nirmatrelvir / ritonavir (Paxlovid) (n=1120) vs. placebo (n=1126)
randomized controlled trial
Nirmatrelvir/ritonavir (Paxlovid)
300 mg of nirmatrelvir plus 100 mg of ritonavir every 12 hours for 5 days
Placebo
Patients were treated within five days of symptom onset.
COVID 19 outpatients
Patients with confirmed SARS-CoV-2 infection within 5 days prior to randomization, with at least 1 characteristic or underlying medical condition associated with an increased risk of developing illness from COVID-19.
Double-blind.
North and South America, Europe, Africa, and Asia.
peginterferon (n=30) vs. placebo (n=30)
randomized controlled trial
Peginterferon lambda-1a
Single 180 µg subcutaneous injection of peginterferon lambda within 7 days ofsymptom onset or first positive swab if asymptomatic.
Placebo
Single 180 µg subcutaneous injection of saline placebo within 7 days ofsymptom onset or first positive swab if asymptomatic.
COVID 19 outpatients
Adult patients between the ages of 18 and 70 years, confirmed COVID-19 infection by PCR within 5 days of symptom onset (fever, respiratory symptoms, sore throat), and discharged to home isolation.
Double-blind.
Multicenter, 6 institutions in Toronto, Canada.
Because of non identical matching placebo, one of two study personnel administering the medication was aware of the treatmentallocation. After administering the medication, all further follow-up (phone calls and study visits) was completed by study personnel unaware of treatment allocation.
Type III Interferon.
remdesivir (n=292) vs. placebo (n=292)
randomized controlled trial
Intravenous remdesivir
Intravenous remdesivir (200 mg on day 1 and 100 mg on days 2 and 3).
Placebo
COVID 19 outpatients
Eligible patients were 12 years of age or older and had at least one preexisting risk factor for progression to severe Covid-19 or were 60 years of age or older, regardless of whether they had other risk factors. Risk factors included hypertension, cardiovascular or cerebrovascular disease, diabetes mellitus, obesity (a body-mass index [BMI; the weight in kilograms divided by the square of the height in meters] of ≥30), immune compromise, chronic mild or moderate kidney disease, chronic liver disease, chronic lung disease,current cancer, or sickle cell disease.
Double-blind.
64 sites in the US, Spain, Denmark, UK.
The primary efficacy end point was initially a composite of hospitalization for any cause or death from any cause by day 14 and was modified on January 14, 2021, in response to comments from the Food and Drug Administration; trial blinding was maintained. No interim statistical analyses were performed.
On April 6, 2021, an orderly closure of trial enrollment was announced by the sponsor because of administrative reasons related to a decrease in the incidence of SARS-CoV-2 infections, ethical concerns regarding assigning patients to placebo in the context of increased access to emergency-use–authorized treatments such as monoclonal antibodies, and increasing vaccination rates among high-risk persons.
sofosbuvir and daclatasvir (n=30) vs. standard of care (n=30)
randomized controlled trial
Sofosbuvir/Daclatasvir
Single daily oral tablet containing 400 mg sofosbuvir and 60mg daclatasvir with hydroxychloroquine 200mg twice daily, for 7 days, or until death/hospitalization.
Standard of care
Hydroxychloroquine.
Hydroxychloroquine in both groups. All patients received standard care according to the national Iranian treatment guidelines. All patients received azithromycin capsules (500mg for 6 days) with naproxen tablets (500mg, twice daily for 7 days), as well as40mg pantoprazole tablets.
COVID 19 outpatients
Patients excluded if oxygen saturation less than 93%.
Double-blind.
Single center, Miandrood Outpatient Medical Clinic in Surak, Mazandaran, Iran.
At Days 1, 3 and 5 patients were followed-up by phone call and at Day 7 by a personalvisit. At 30 days from enrolment, patients were followed-up by phone call to monitor fatigue, shortness of breath and anorexia.
sotrovimab (Xevudy; VIR-7831) (n=528) vs. placebo (n=529)
randomized controlled trial
Sotrovimab (VIR-7831, GSK4182136) as monotherapy
Intravenous infusion of sotrovimab 500 mg over 1 hour on day 1.
Placebo
Equal volume of saline placebo over 1 hour on day 1.
Patients were observed for approximately 2 hours after infusion.
COVID 19 outpatients
18 years of age and older with at least one of the following comorbidities: diabetes, obesity (BMI >30), chronic kidney disease, congestive heart failure, chronic obstructive pulmonary disease, or moderate to severe asthma, or were 55 years of age and older regardless of comorbidities. Participants must have a positive SARS-CoV-2 test result and oxygen saturation ≥94% on room air and have COVID-19 symptoms and be less than or equal to 5 days from onset of symptoms
Double-blind.
57 centers in 5 countries: US, Brazil, Spain, Canada, Peru.
*Warning! The spread of new Sars-Cov2 variants is constantly evolving, this study was performed in a different viral context than today, its results should be interpreted accordingly.* data reported in FDA emergency use authorization (EUA), results from interim analysis.
vitamin C (n=48) vs. standard of care (n=50)
randomized controlled trial
Ascorbic acid (high dose)
8000 mg of ascorbic acid (to be divided over 2-3 times per day with meals).
Standard of care
Usual care without any study medications.
4 arms: standard of care, ascorbic acid only, zinc only, ascorbic acid and zinc association.
COVID 19 outpatients
Outpatients ≥ 18 years presenting to Cleveland Clinic Health System in Ohio and Florida who test positive for COVID-19 having any of thefollowing symptoms: fever or chills, shortness of breath or difficulty breathing, cough, fatigue, muscle or body Aches, headache, new loss of taste, new loss of smell, congestion or runny nose, nausea, vomiting, diarrhea.
Open-label.
Cleveland Clinic Main Campus Cleveland, Ohio and Florida
Patients were asked to track their systemic illness daily based on symptoms. Patients recorded a questionnaire with only 4 symptoms (ie, fever/chills, shortness of breath, cough, and fatigue) for scores ranging from 0 to 12. For each symptom, the patients assigned a score of 0 to 3 (with 0 indicating no symptoms; 1, mild symptoms; 2, moderate symptoms; and 3, severe symptoms).
The study was stopped for a low conditional power for benefit with no significant difference among the 4 groups for the primary end point.
zinc plus vitamin c (n=58) vs. standard of care (n=50)
randomized controlled trial
Ascorbic acid (high dose) plus zinc (high dose)
8000 mg of ascorbic acid (to be divided over 2-3 times per day with meals) plus 50mg of zinc gluconate at bedtime.
Standard of care
Usual care without any study medications.
4 arms: standard of care, ascorbic acid only, zinc only, ascorbic acid and zinc association.
COVID 19 outpatients
Outpatients ≥ 18 years presenting to Cleveland Clinic Health System in Ohio and Florida who test positive for COVID-19 having any of thefollowing symptoms: fever or chills, shortness of breath or difficulty breathing, cough, fatigue, muscle or body Aches, headache, new loss of taste, new loss of smell, congestion or runny nose, nausea, vomiting, diarrhea.
Open-label.
Cleveland Clinic Main Campus Cleveland, Ohio and Florida
Patients were asked to track their systemic illness daily based on symptoms. Patients recorded a questionnaire with only 4 symptoms (ie, fever/chills, shortness of breath, cough, and fatigue) for scores ranging from 0 to 12. For each symptom, the patients assigned a score of 0 to 3 (with 0 indicating no symptoms; 1, mild symptoms; 2, moderate symptoms; and 3, severe symptoms).
The study was stopped for a low conditional power for benefit with no significant difference among the 4 groups for the primary end point.
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