meta|Evidence - COVID-19
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chloroquine (n=18) vs. standard of care (n=12)
randomized controlled trial high risk of bias
chloroquine
chloroquine phosphate group: First dose of chloroquine phosphate 1 g first day, then 0.5g × 9 days
standard of care
according to the Chinese Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (5th Edition)
3 arms chloroquine, hydroxychloroquine and SoC
COVID 19 all comers
open-label
China, single center
Study planned to recruit 100 subjects with confirmed mild/moderate types ofCOVID-19. Study discontinuated after enrolling only 67 subjects with mild/moderate COVID-19Publication report only data on 48 patients with moderate type of COVID-19
hydroxychloroquine (n=18) vs. standard of care (n=12)
randomized controlled trial high risk of bias
hydroxychloroquine
Hydroxychloroquine sulfate group 0.2 g BID × 10 days
standard of care
according to the Chinese Diagnosis and Treatment Protocol for Novel Coronavirus Pneumonia (5th Edition)
COVID 19 all comers
open-label
China, single center
Study planned to recruit 100 subjects with confirmed mild/moderate types ofCOVID-19. Study discontinuated after enrolling only 67 subjects with mild/moderate COVID-19Publication report only data on 48 patients with moderate type of COVID-19
chloroquine (n=10) vs. lopinavir/ritonavir (n=12)
randomized controlled trial some concerns about risk of bias
chloroquine 500 mg orally twice daily for 10 days
Lopinavir/Ritonavir 400/100 mg orally twice daily for 10 days
COVID 19 hospitalized
open label
China, Zhuhai
Fifth Affiliated Hospital of Sun Yat-sen University in Zhuhai
hydroxychloroquine (n=42) vs. azithromycin (n=43)
randomized controlled trial some concerns about risk of bias
hydroxychloroquine
hydroxychloroquine 400 mg by mouth twice daily for 1 day, then 200 mg by mouth twice daily for 4 days (dose reductions for weight < 45 kg or GFR (glomerular filtration rate)<50ml/min)
azithromycin
azithromycin 500 mg on day 1 plus 250 mg daily on days 2-5 (may be administered intravenously per clinician preference). if the patient has already received azithromycin prior to randomization, the prior doses will count toward the 5-day total
COVID 19 hospitalized
enrolled within 48 hours of hospital admissioncurrent known Qtc>500 msec
open label
united states, 13 centres
300 participants. Trial was stopped early afterenrollment of 85 patients when a separate clinical trial concluded that a clinically important effect of hydroxychloroquine over placebo was definitively excluded
hydroxychloroquine (n=124) vs. placebo (n=123)
randomized controlled trial some concerns about risk of bias
hydroxychloroquine
2x400 mg Day 1 , then 2x200mg/d for 8 days
placebo
COVID 19 hospitalized
double blind
34 centres, France
The trial was stopped after 250 patients were included due to a slowdown of the pandemic in France
hydroxychloroquine (n=242) vs. placebo (n=237)
randomized controlled trial low risk of bias
hydroxychloroquine
hydroxychloroquine (400 mg twice daily for 2 doses, then 200 mg twice daily for 8 doses)
placebo
COVID 19 hospitalized
hospitalized for less than 48 hours with laboratory-confirmed SARS-CoV-2 infection andsymptoms of respiratory illness for less than 10 days were enrolled
double-blind, randomized
US, 34 centers
trial was stopped at the fourth interim analysis for futility with a sample size of 479 patients. The scale consisted of 7 mutually exclusivecategories: 1, death; 2, hospitalized, receiving extracorporealmembrane oxygenation (ECMO) or invasive mechanicalventilation; 3, hospitalized, receiving noninvasive mechanicalventilation or nasal high-flow oxygen therapy; 4, hospitalized,receiving supplemental oxygen without positivepressure or high flow; 5, hospitalized, not receiving supplementaloxygen; 6, not hospitalized and unable to performnormal activities; and 7, not hospitalized and able to performnormal activities.
hydroxychloroquine (n=33) vs. placebo (n=37)
randomized controlled trial some concerns about risk of bias
hydroxychloroquine
400 mg every 12 hours on the first day, followed by 200 mg every 12 hours for another 4 days
Placebo
COVID 19 hospitalized
Patients with 1) positive RT-PCR for SARS-CoV-2 by nasal and oropharyngeal swabbing, 2) Pneumonia, diagnosed by X-ray or high-resolution chest CTscan, with a pattern suggesting involvement due to coronavirus, 3) Recently established hypoxemic respiratory failure or acute clinical deterioration of pre-existing lung or heartdisease. Patients were excluded if they required high oxygen volumes (face mask > 10 L/ min), if they had predictors of a poor response to high-flow oxygen nasal prong therapy or if they required mechanical ventilation.
Double-blind.
Single center, Mexico.
3 arms : hydroxychloroquine, ivermectin, or placebo.study interrupted early only 108 patients included out of 200 patients anticipated
hydroxychloroquine (n=67) vs. placebo (n=61)
randomized controlled trial some concerns about risk of bias
hydroxyxhloroquine
2x400 mg on day 1, then 2x200mg/day for 4 days
placebo
COVID 19 hospitalized
626 patients would need to be enrolled to provide 80% power
double blind
2 centres, USA
Randomization was stratified by age (>60 years old) and study site
hydroxychloroquine (n=10) vs. standard of care (n=6)
randomized controlled trial risk of bias NA
hydroxychloroquine
400 mg 2x day on day 1, followed by 200 mg 2x day days 2-5
standard of care
COVID 19 hospitalized
open-label
1 center, Hawaii
found in Axfors et al. meta-analysis
hydroxychloroquine (n=947) vs. standard of care (n=906)
randomized controlled trial some concerns about risk of bias
hydroxychloroquine
Day 1 H0 800 mg, H6 800 mg then since H12 400 mg twice daily for 10 days
standard of care
COVID 19 hospitalized
open label
405 hospitals in 30 countries
7 June 2020 : WHO announced that the hydroxychloroquine (HCQ) arm of the Solidarity Trial to find an effective COVID-19 treatment was being stopped,18 June 2020 : Hydroxychloroquine arm was discontinued for futility
hydroxychloroquine (n=-9) vs. standard of care (n=-9)
randomized controlled trial risk of bias NA
COVID 19 hospitalized
double blinded
hydroxychloroquine (n=4) vs. standard of care (n=2)
randomized controlled trial risk of bias NA
hydroxychloroquine
800 mg on day 1, followed by 600 mg daily on days 2-5
standard of care
4 arms : standard of care, HCQ, AZI HCQ, AZI
COVID 19 hospitalized
open- label
4 centers, USA
hydroxychloroquine (n=9) vs. standard of care (n=6)
randomized controlled trial risk of bias NA
hydroxychloroquine
loading dose 400mg bid followed by 200mg twice a day; total treatment duration 5 days
standard of care
no antiviral
COVID 19 hospitalized
open label
Netherlans
found in Axfors et al. meta-analysis
hydroxychloroquine (n=2) vs. standard of care (n=3)
randomized controlled trial risk of bias NA
hydroxychloroquine azi
drug: hydroxychloroquinehydroxychloroquine will be administered orally or via feeding tube at a dosage of 800 mg on day 1, followed by 600 mg daily on days 2-5
standard of care azithromycin
factorial design with azithromycin
COVID 19 hospitalized
hospitalized patients with confirmed SARS-coV-2 infection
open label
united states
pragmatic factorial randomized trial
Found in Afors et al
hydroxychloroquine (n=21) vs. standard of care (n=12)
randomized controlled trial some concerns about risk of bias
hydroxychloroquine
HCQ 400 mg twice for 1 d and HCQ 200 mg twice daily for 6 days
standard of care
supportive treatment for subjects with mild clinical COVID-19 symptoms and antimicrobial therapy for subjects presenting with moderate clinical COVID-19 symptoms
AZI co-administration allowed. only 1 patient 1 HCQ group and 2 in control group
COVID 19 hospitalized
Patient stratified into three groups : mild illness, moderate illness and severe illness. Patient with severe illness were excluded from this study
open-label
11 designated public hospitals in Taiwan
Publication present results of RCT and a retrospective study (medical records). In the retrospective study, 12 (42.9%) in the HCQ group and 5 (55.6%) in the control group had negative rRT-PCR results on hospital day 14 (p = 0.70).
hydroxychloroquine (n=75) vs. standard of care (n=75)
randomized controlled trial high risk of bias
hydroxychloroquine 800mg
hydroxychloroquine loading dose of 1, 200 mg daily for three days followed by a maintained dose of 800 mg daily for the remaining days for 2 or 3 weeks
standard of care
COVID 19 hospitalized
open label
16 centers in China
prematurely discontinuated for efficacy on secondary post hoc criteria, no adjustment for multiplicity
lesser included patients than the 200 initialy planned. Several criteria were uninterpretable because not all patients included were appropriate for measuring these criteria
hydroxychloroquine (n=27) vs. standard of care (n=26)
randomized controlled trial some concerns about risk of bias
hydroxychloroquine
400 mg twice daily for seven days
standard of care
COVID 19 hospitalized
open label
1 center, Norway
hydroxychloroquine (n=1561) vs. standard of care (n=3155)
randomized controlled trial some concerns about risk of bias
hydroxychloroquine
400mg after loading dose
no additional treatment.
Factorial design, 5 arms for the first randomisation and convalescent plasma for the second randomisation
COVID 19 hospitalized
open-label
175 NHS hospitals in the UK
hydroxychloroquine (n=-9) vs. standard of care (n=-9)
randomized controlled trial risk of bias NA
hydroxychloroquine azithromycine
600 mg/d for 5 days
azithromycine
COVID 19 hospitalized
open label
11 centers, Pakistan
found in Axfors et al meta analysis
hydroxychloroquine (n=97) vs. standard of care (n=97)
randomized controlled trial some concerns about risk of bias
hydroxychloroquine
hydroxychloroquine added to standard care400 mg twice daily (in day 1) followed by 200 mg tablets twice daily for 15 days
standard of care
Standard of care : standard of care : paracetamol, oxygen, fluids (according to assessment), empiric antibiotic (cephalosporins), oseltamivir if needed (75 mg/ 12 hours for 5 days), and invasive mechanical ventilation with hydrocortisone for severe cases
COVID 19 hospitalized
patients with cardiac problem (chronic heart failure or prolonged QT interval on electrocardiogram [ECG]) were excluded from the study.
open-label
three major university hospitals in Egypt
randomization by strate
hydroxychloroquine (n=62) vs. standard of care (n=63)
randomized controlled trial risk of bias NA
hydroxychloroquine oseltamivir
600 mg/d for 5 days
oseltamivir
COVID 19 hospitalized
open label
11 centers, Pakistan
found in Axfors et al meta analysis
chloroquine (n=-9) vs. placebo (n=-9)
randomized controlled trial risk of bias NA
chloroquine
450 mg x2 day 1, then 450 mg/d for 4 days
placebo
COVID-19 mild to moderate
double-blind
1 center, Brazil
found in Axfors et al meta-analysis
hydroxychloroquine (n=-9) vs. placebo (n=-9)
randomized controlled trial risk of bias NA
hydroxychloroquine
placebo
COVID-19 mild to moderate
double blind
international
found in Axfors et al meta-analysisTerminated (Rate of enrollment too slow to allow completion in a reasonable timeframe
hydroxychloroquine (n=360) vs. standard of care (n=180)
randomized controlled trial high risk of bias
Hydroxychloroquine
Standard of care plus hydroxychloroquine 400mg twice daily on day 1, then 200mg twice daily for the next 5 days.
Standard of care
SOC treatment comprised daily oral vitamin C (2 g), oral zinc (50 mg), oral vitamin D(alfacalcidol 1 µg), and oral acetaminophen (for body aches and fever).
2:1 ratio. All patients received standard of care.
COVID-19 mild to moderate
Adult patients (18-80) with mild COVID-19 (PCR confirmed infection) and hospitalized.
Open-label.
Single-center; Pak Emirates Military Hospital, Rawalpindi, Pakistan.
Progression of disease was defined by the development of fever >101°F for >72 hours, shortness of breath with minimal exertion, derangement of basic laboratory parameters (ALC < 1000 or raised CRP), or appearance of infiltrates on X-ray chest.
hydroxychloroquine (n=221) vs. standard of care (n=227)
randomized controlled trial some concerns about risk of bias
hydroxychloroquine at a dose of 400 mg twice daily
hydroxychloroquine [400mg 2x/day, 12/12h] for 7 days
standard of care
The use of glucocorticoids, other immunomodulators, antibiotic agents, and antiviral agents was allowed
3 arms: hydroxychloroquine plus azythromycin, hydroxychloroquine monotherapy and standard of care
COVID-19 mild to moderate
open-label
Brazil, 55 sites
Randomization was performed in blocks of six and was stratified according to the use or nonuse of supplemental oxygen at the time of randomization
hydroxychloroquine (n=15) vs. standard of care (n=15)
randomized controlled trial high risk of bias
hydroxychloroquine 400mg
hydroxychloroquine 400mg per day for 5 days
standard of care
COVID-19 mild to moderate
open-label
China
paper in chinese
hydroxychloroquine (n=125) vs. standard of care (n=129)
randomized controlled trial some concerns about risk of bias
Favipiravir and Hydroxychloroquine
Favipiravir: 1800 mg twice daily for one day, followed by 800mg (total days of therapy is 10 days or till hospital discharge)Hydroxychloroquine (400mg) twice daily on day 1; for days 2-5 (200mg) twice daily.
standard of care
COVID-19 mild to moderate
open label
9 centers, Saudi Arabia
Moderate or Severe confirmed COVID-19
Trial stopped for futility after the first interim analysis
hydroxychloroquine (n=31) vs. standard of care (n=31)
randomized controlled trial high risk of bias
hydroxychloroquine 400mg
additional oral HCQ (hydroxychloroquine sulfate tablets, Shanghai Pharma) 400 mg/d (200 mg/bid) between days 1 and 5
standard of care
COVID-19 mild to moderate
(RT-PCR) positive of SARS-coV-2; chest CT with pneumonia; saO2/SPO2 ratio > 93% or paO2/FIO2 ratio > 300 mmhg under room air
open-label
China, single center
there is some changes in the publication compared to the registry record (open control in place of placebo, sample size and the primary endpoint changed that does rule out the possibility of a selective publication bias)
hydroxychloroquine (n=106) vs. placebo (n=108)
randomized controlled trial some concerns about risk of bias
hydroxychloroquine
200x2 for 10 days
placebo
COVID-19 severe or critically
double-blind
3 centres, Mexico
pr-specified sample size : 300 vs 300. In mid-July, 2020, the rhythm of recruitment was reduced drastically, due to severalreasons including patient refusal, that of their relatives, or that of their treating physicians,coinciding with the worldwide suspension of several large trials testing HCQ in which no benefitsof the drug were found
hydroxychloroquine (n=61) vs. standard of care (n=81)
randomized controlled trial risk of bias NA
hydroxychloroquine
Loading dose of 800mg hydroxychloroquine administered enterally every 6 hours until 2 doses have been administered. Subsequently, 400mg hydroxychloroquine will be administered enterally every 12 hours for 12 doses or ICU discharge
standar of care
COVID-19 severe or critically
open label
90 centers, international
found in Axfors et al. meta-analysis
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