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bamlanivimab monotherapy (n=588) vs. placebo (n=587)
randomized controlled trial
Bamlanivimab
Single intravenous infusion of bamlanivimab 4200mg.
Placebo
COVID-19 prophylaxis (excluding children)
All participants were aged 18 years or older and had no known history of COVID-19. Participants provided both nasal and nasopharyngeal swabs (baseline samples) for detection of SARS-CoV-2 by reverse transcriptase–polymerase chain reaction (RT-PCR) and blood samples for SARS-CoV-2 serology tests.
Double-blind.
74 facilities in the United States.
The evaluation period was 8 weeks, with follow-up to 24 weeks. Mild or worse disease severity included mild, moderate, severe, and critical disease severity and death due to COVID-19. The trial enrolled residents and staff at 74 skilled nursing and assisted living facilities in the United States (California, Colorado, Florida, Illinois, Indiana, Kentucky, Missouri, North Carolina, Ohio, Pennsylvania, and Virginia). All 74 facilities had at least 1 confirmed SARS-CoV-2 index case.
EMA ends rolling review of the antibodies bamlanivimab and etesevimab for COVID-19 following withdrawal by Lilly. < Study carried out before the release of the omicron variant >
casirivimab/imdevimab (Ronapreve) (n=753) vs. placebo (n=752)
randomized controlled trial
REGEN-COV (casirivimab 600mg plus imdevimab 600mg)
Single dose of REGEN-COV 1200 mg at day 1 via subcutaneous injection.
Placebo
Placebo at day 1 via subcutaneous injection.
COVID-19 prophylaxis (excluding children)
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.*
cilgavimab and tixagevimab (Evusheld) (n=3460) vs. placebo (n=1737)
randomized controlled trial
tixagevimab (AZD8895) and cilgavimab (AZD1061)
single dose (two consecutive intramuscular injections, one containing tixagevimab and the other containing cilgavimab) of 300 mg of AZD7442
placebo
COVID-19 prophylaxis (excluding children)
double-blind
87 sites in the US, UK, Spain, France and Belgium
*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.* preliminary results reported in a press release https://www.astrazeneca.com/media-centre/press-releases/2021/azd7442-prophylaxis-trial-met-primary-endpoint.html
Comirnaty (tozinameran - Pfizer/BIONTECH) (n=21720) vs. placebo (n=21728)
randomized controlled trial
BNT162b2
two doses, 21 days apart, of BNT162b2 vaccine candidate (30 μg per dose)
placebo
COVID-19 prophylaxis (excluding children)
Adults 16 years of age or older who were healthy or had stable chronic medical conditions, including but not limited to human immunodeficiency virus (HIV), hepatitis B virus, or hepatitis C virus infection. Key exclusion criteria included a medical history of Covid-19, treatment with immunosuppressive therapy, or diagnosis with an immunocompromising condition
double-blind
152 sites worldwide
phase1/2/3 study (seamless)
Comirnaty - first boost (n=5081) vs. Comirnaty (tozinameran - Pfizer/BIONTECH) (n=5044)
randomized controlled trial
BNT162b2 vaccine
third dose
placebo
participants had previously received 2 doses of Comirnaty
COVID-19 prophylaxis (excluding children)
single-blind
123 sites in the United States, South Africa, and Brazil
During the interim analysis, the data monitoring committee recommended that participants be made aware of their trial-group assignments to allow those in the placebo group to receive a third vaccine dose. Data from participants who were made aware of trial-group assignments before the first interim analysis because of the regulatory decision were censored at the time of the unblinding of the trial group.
hydroxychloroquine (n=414) vs. placebo (n=407)
randomized controlled trial
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=65) vs. placebo (n=65)
randomized controlled trial
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=407) vs. placebo (n=422)
randomized controlled trial
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=683) vs. placebo (n=676)
randomized controlled trial
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=495) vs. placebo (n=494)
randomized controlled trial
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=66) vs. placebo (n=66)
randomized controlled trial
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=231) vs. placebo (n=223)
randomized controlled trial
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=1116) vs. standard of care (n=1198)
randomized controlled trial
hydroxychloroquine 800mg once, followed by 400mg daily for 6 days
standard of care
COVID-19 prophylaxis (excluding children)
open-label
Catalonia, Spain
Janssen AD26 vaccine (JNJ-78436735) (n=21895) vs. placebo (n=21888)
randomized controlled trial
Janssen Ad26.COV2.S vaccine single dose (5x1010 vp) intramuscular
placebo
COVID-19 prophylaxis (excluding children)
double blind
Argentina, Brazil, Chile, Colombia, Mexico, Peru, South Africa, and the United States
Nuvaxovid (NVX-CoV2373) Novavax (n=-9) vs. placebo (n=-9)
randomized controlled trial
NVX-CoV2373
placebo
COVID-19 prophylaxis (excluding children)
observer-blinded
119 locations in the United States and Mexico
Efficacy endpoints were accrued from January 25 through April 30, 2021, a time when the Alpha (B.1.1.7) variant became the predominant strain in the U.S
Nuvaxovid (NVX-CoV2373) Novavax (n=2199) vs. placebo (n=2188)
randomized controlled trial
NVX-CoV2373 2 doses
two doses, administered 21 days apart, of NVX-CoV2373 nanoparticle vaccine(5 μg recombinant spike protein with 50 μg Matrix-M1 adjuvant)
placebo
COVID-19 prophylaxis (excluding children)
B.1.351 (501Y.V2) variant was largely predominant during trial efficacy endpoint accrual
double-blind
South Africa
phase 2a/b
Spikevax (Moderna mRNA-1273 COVID-19 vaccine) (n=15181) vs. placebo (n=15170)
randomized controlled trial
mRNA-1273 vaccine
100 μg of mRNA-1273 two-dose schedule given one month apart
placebo
saline placebo two-dose schedule given one month apart
COVID-19 prophylaxis (excluding children)
double blind
100 centres, USA
Randomization was stratified based on age and the presence or absence of risk factors for severe illness for COVID-19
Vaxzevria (AstraZeneca Oxford - ChAdOx1 nCoV-19) (n=5807) vs. control (n=5829)
randomized controlled trial
ChAdOx1 nCoV-19 vaccine
ChAdOx1nCoV-19 group received two doses containing 5 × 10¹⁰ viral particles (standard dose; SD/SD cohort); a subset in the UK trial received a half dose as their first dose (low dose) and a standard dose as their second dose (LD/SD cohort)
meningococcal group A, C, W, and Y conjugate vaccine or saline
interval between dose 1 and dose 2 ranged from 4 to 26 weeks
COVID-19 prophylaxis (excluding children)
exclusion criteria: h history of anaphylaxis or angioedema; participants with severe and/or uncontrolled cardiovascular, gastrointestinal, liver, renal, endocrine/metabolic disease, and neurological illnesses; as well as those with immunosuppression
double blind
UK, Brazil, and South Africa.
pooled analysis of 4 studies done across the UK, Brazil, and South Africa : ISRCTN89951424(COV003), NCT04400838 (COV002), NCT04324606 (COV001), and NCT04444674 (COV005).
vitamin C (n=73) vs. control (n=45)
randomized controlled trial
Quercetin, vitamin C, bromelain (QCB)
Supplementation containing 500mg of quercetin, 500mg of vitamin C and 50mg of bromelain (QCB) was initiated daily in 2 divided doses.
Control group
Control group without using supplements.
COVID-19 prophylaxis (excluding children)
Healthcare professionals (aged between 20-60 years) working in areas of high exposure and high risk of transmission of SARS-COV-2 (COVID areas, Intensive Care Unit (ICU), Emergency Department, Anesthesia Inpatient and Outpatient Clinics, Dialysis Units andhealthcare frontiers who perform all those aerosol-generating procedures), without history of COVID-19.
Open-label.
Single center, Kanuni Sultan Suleyman Training and Research Hospital, Istanbul, Turkey.
At the end of the follow-up period, COVID-19 rapid diagnostic tests (RDT) were used to detect COVID-19 IgG and M positivity in all cases.While computerized axial tomography (CAT) scan is being used for diagnosis of COVID-19, accurate diagnosis is established by reverse transcriptase chain reaction (RT- PCR).
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