meta|Evidence - COVID-19
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bromhexine (n=25) vs. control (n=25)
randomized controlled trial risk of bias NA
Bromhexine hydrochloride
Bromhexine hydrochloride 8 mg 3 times per day starting from the day before the first contact with COVID-19 (first day of work in an infection department).
Control
Without any placebo/additional drug prescribed.
COVID-19 prophylaxis (excluding children)
Participants over 18 years who were employed within the emergency departments where patients with confirmed/suspected COVID-19 were admitted, intensive care units, and clinical departments. All participants were obliged to wear personal protective equipment (PPE) as prescribed by WHO recommendations and local instructions. The PPE included respirators class FFP2 or FFP3, full skin covering, and protective eyeglasses.Participants were excluded if they had symptoms of respiratory infection within the last 2 months or a history of COVID-19, or a positive nasopharyngeal swab polymerase chain reaction (PCR) test to SARS-CoV-2 before the day of randomization, a confirmed direct contact to a subject positive for SARS-CoV-2 within the last 14 days or had a positive serologic test (either IgM or IgG).
Open-label.
Single center,
Follow-up phone calls and e-mail surveys on days 7, 14, 21, 28, and at week 8, nasopharyngeal swab SARS-CoV-2 PCR tests performed every 7 days. COVID-19–related symptoms were assessed based on the U.S. Council for State and Territorial Epidemiologists Criteria for confirmed cases (positive nasopharyngeal swab PCR test), probable cases (the presence of cough, shortness of breath, or difficult breathing, or the presence of two or more symptoms of fever, chills, rigors, myalgia, headache, sore throat, and new olfactory and taste disorders), and possible cases (the presence of one or more compatible symptoms, which could include diarrhea).
hydroxychloroquine (n=142) vs. placebo (n=127)
randomized controlled trial high risk of bias
hydroxychloroquine
400mg/d for the first 4 days and subsequently, 400mg weekly during the study period.
placebo
COVID-19 prophylaxis (excluding children)
double blind
3 hospitals centers, Barcelona
hydroxychloroquine (n=414) vs. placebo (n=407)
randomized controlled trial low risk of bias
hydroxychloroquine
hydroxychloroquine (800 mg once, followed by 600 mg in 6 to 8 hours, then 600 mg daily for 4 additional days)
placebo
folate
COVID-19 prophylaxis (excluding children)
adults who had household or occupational exposure to someone with confirmed Covid-19 at a distance of less than 6 ft for more than 10 minutes while wearing neither a face mask nor an eye shield (high-risk exposure) or while wearing a face mask but no eye shield (moderate-risk exposure)
double-blind
United States, Canada
prematurely stopped at the third interim analysis for futility
hydroxychloroquine (n=495) vs. placebo (n=494)
randomized controlled trial low risk of bias
hydroxychloroquine
hydroxychloroquine:loading dose of 400mg (two 200mg tablets) twice separated by 6-8 hours thereafter 400mg twice weekly for 12 weeks
placebo
placebo
3 arms : hydroxychloroquine 400mg weekly ; hyrdoxychloroquine 400mg twice weekly ; placebo
COVID-19 prophylaxis (excluding children)
persons working in emergency departments, persons working in intensive care units, persons performing aerosol generating procedures, first responders
double-blind, randomized
USA Canada
hydroxychloroquine (n=65) vs. placebo (n=65)
randomized controlled trial some concerns about risk of bias
Hydroxychloroquine
Hydroxychloroquine 200mg per day for 60 days.
Placebo
COVID-19 prophylaxis (excluding children)
Healthcare workers (nurses, nursing aides, cleaning staff, orderlies, respiratory therapists and physicians) 18 years old or older, with high-risk exposure to SARS-Cov-2 as they were taking care of hospitalized patients with COVID19. At baseline, included subjects had to be asymptomatic with a negative PCR-RT SARS-CoV2 test. Subjects with previous SARS-CoV2 infection or actual consumers of hydroxychloroquine or chloroquine (a 30 day wash out period was allowed) were excluded.
Double-blind.
Single center; National Institute of Respiratory Diseases (INER), Mexico.
In the register, PE was the rate of symptomatic COVID-19 infection. All subjects were asked to report their symptoms daily via an online survey, with reminders and links being sent with a popular phone application (WhatsApp) to the phone number provided in the baseline evaluation. Subjects were also encouraged to contact the research team directly in case of a probable COVID-19 or adverse event symptom. A new RT-PCR for SARS-COV-2 was performed if subjects presented with COVID19 symptoms.
Study failed to complete estimated sample size. Trial was suspended due to a drastic reduction of recruitment rythm and a lack of benefit of hydroxychloroquine reported from other trials.
hydroxychloroquine (n=66) vs. placebo (n=66)
randomized controlled trial some concerns about risk of bias
hydroxychloroquine
600 mg once a day for 2 months
placebo
COVID-19 prophylaxis (excluding children)
double blind
2 tertiary urban hospitals,USA
early termination for futility
early termination for futility
hydroxychloroquine (n=154) vs. placebo (n=46)
randomized controlled trial high risk of bias
one to three received HCQ in various doses
placebo
Group 1 participants (n=48) were intervened with HCQ 400 mg twice a day on day 1 followed by 400 mg weekly. Group 2 (n=51) with HCQ 400 mg once every three weeks, Group 3 (n=55) with HCQ 200 mg once every three weeks
COVID-19 prophylaxis (excluding children)
double-blind
Pakistan
hydroxychloroquine (n=407) vs. placebo (n=422)
randomized controlled trial low risk of bias
hydroxychloroquine
hydrochloroquine 400 mg orally daily for 3 days, then 200 mg orally daily for 11 days
placebo
ascorbic acid 500 mg orally daily for 3 days, then 250 mg orally daily for 11 days
prophylaxis
COVID-19 prophylaxis (excluding children)
close contact defined as: household contact, medical staff who cared for the index case without personal protectionaccess to device and internet for telehealth visits are require
single blind
7 centres, USA
pharmacist was unblinded, but the participants, investigators, laboratory technicians, and study team members were blinded to participant allocation
hydroxychloroquine (n=65) vs. placebo (n=65)
- risk of bias NA
hydroxychloroquine
Hydroxychloroquine - 600 mg, daily
COVID-19 prophylaxis (excluding children)
double-blind
2 centers ; USA
After the second preplanned. The trial was terminated early for futility before reaching a plannedenrollment of 200 participants
hydroxychloroquine (n=231) vs. placebo (n=223)
randomized controlled trial some concerns about risk of bias
Daily hydroxychloroquine for 12 weeks
placebo
COVID-19 prophylaxis (excluding children)
double blind
Spain, Bolivia, and Venezuela
2x2 factorial design but analyzed as 4 groups
hydroxychloroquine (n=683) vs. placebo (n=676)
randomized controlled trial some concerns about risk of bias
hydroxychloroquine
loading dose of HCQ 600 mg twice on Day 1 followed by 400 mg daily for 29 days
placebo
COVID-19 prophylaxis (excluding children)
double blind, randomized
34 clinical centers in the United States
Enrollment for the study was closed before full accrual due to difficulties recruiting additional participants
hydroxychloroquine (n=1116) vs. standard of care (n=1198)
randomized controlled trial some concerns about risk of bias
hydroxychloroquine 800mg once, followed by 400mg daily for 6 days
standard of care
COVID-19 prophylaxis (excluding children)
open-label
Catalonia, Spain
hydroxychloroquine (n=432) vs. vitamin C (n=619)
randomized controlled trial high risk of bias
42-day prophylaxis regimen of oral hydroxychloroquine (400 mg once, followed by 200 mg/day)
oral vitamin C, 500 mg/day.
COVID-19 prophylaxis (excluding children)
open-label
Singapore
cluster randomisation
ivermectin (n=117) vs. control (n=117)
randomized controlled trial high risk of bias
Ivermectin / lota carrageenan
Ivermectin orally 2 drops of 6 mg = 12 mg every 7 days, and Iota-Carrageenan 6 sprays per day for 4 weeks
Control
COVID-19 prophylaxis (excluding children)
open-label
1 center, Argentina
ivermectin (n=228) vs. standard of care (n=112)
randomized controlled trial high risk of bias
ivermectin
two doses 72 hours apart
standard of care
COVID-19 prophylaxis (excluding children)
open label
1 center, Egypt
ivermectin (n=617) vs. vitamin C (n=619)
randomized controlled trial high risk of bias
oral ivermectin (12 mg once) 42 day
oral vitamin C, 500 mg/day
arm study: oral hydroxychloroquine (400 mg once, followed by 200 mg/day), oral ivermectin (12 mg once), povidone-iodine throat spray (3 times/day, 270 μg/day), oral zinc (80 mg/day)/vitamin C (500 mg/day) combination, or oral vitamin C, 500 mg/day
COVID-19 prophylaxis (excluding children)
open label
Singapore
cluster trial
nirmatrelvir / ritonavir (Paxlovid) (n=2634) vs. placebo (n=-9)
randomized controlled trial risk of bias NA
Paxlovid for five days followed by placebo for 5 days or paxlovid for ten days
Nirmatrelvir/ritonavir
placebo
3 arms : Paxlovid for 5 days followed by placebo for 5 days or Paxlovid for 10 days or Placebo for 10 days
COVID-19 prophylaxis (excluding children)
double blind
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