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azithromycin (n=172) vs. standard of care (n=159)
randomized controlled trial
azithromycin plus hydroxychloroquine
standard care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily for 7 days
hydroxychloroquine
standard care plus hydroxychloroquine at a dose of 400 mg twice dailyThe use of glucocorticoids, other immunomodulators, antibiotic agents others than macrolides , 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
azithromycin (n=107) vs. standard of care (n=99)
randomized controlled trial
azithromycin
azithromycin 500 mg/24 h for 7 days
standard of care
3 arms azithromycin, clarithromycin or standard of care
COVID-19 mild to moderate
open-label
1 centre, Egypt
azithromycin plus hydroxychloroquine (n=217) vs. standard of care (n=227)
randomized controlled trial
Hydroxychloroquine plus azithromycin
Standard of care plus hydroxychloroquine at a dose of 400 mg twice daily plus azithromycin at a dose of 500 mg once daily 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 (1:1:1 ratio). All patients received standard of care.
COVID-19 mild to moderate
Adult patients (18 years and older) with suspected or confirmed COVID-19 admitted to inpatients units and intensive care units. Patients using non-invasive ventilation or invasive mechanical ventilation were excluded. Patients with previous use of chloroquine, hydroxychloroquine, azithromycin or any other macrolide for more than 24h before enrollment were excluded.
Open-label.
Multicenter; 55 sites in Brazil.
Scores on the scale were defined as follows: a score of 1 indicated not hospitalized with no limitations on activities; 2, not hospitalized but with limitations on activities; 3, hospitalized and not receiving supplemental oxygen; 4,hospitalized and receiving supplemental oxygen;5, hospitalized and receiving oxygen supplementation administered by a high-flow nasal cannula or noninvasive ventilation; 6, hospitalized and receiving mechanical ventilation; and 7, death.
3 interim analyses planned, only the first one was conducted.
azvudine (n=10) vs. antiviral and associated therapy (n=10)
randomized controlled trial
Azvudine
Oral azvudine tablets 5 mg/day (five tablets once a night) and symptomatic treatment.
Standard antiviral
interferon alpha, kaletra and ribavirin, chloroquine phosphate, and hydroxychloroquine sulfate
When patients developed clinical symptoms and signs, such as fever and cough, patients in both groups were treated with febrifuge or cough mixture, which was called symptomatic treatment.
COVID-19 mild to moderate
Confirmed COVID-19 by RT-PCR. The definition of mild COVID-19 was patients with mild clinical symptoms and without signs of pneumonia in imaging; the definition of commonCOVID-19 was patients with fever, respiratory, or other related symptoms, and with signs of pneumonia in imaging. Patients with one of the following conditions: respiratory failure and the need for mechanical ventilation; shock; intensive care unit (ICU) monitoring and treatment for other organ failures were excluded.
Open-label
Single center, Guangshan County People’s Hospital, China.
bromhexine (n=12) vs. standard of care (n=6)
randomized controlled trial
Bromhexine hydrochloride
Patients in the treatment group received BRH tablets (32 mg t.i.d.) three times per day after meals for 14 consecutive days. Treatment was discontinued once the patient met the discharge criteria.
Standard of care
Antiviral drugs, including arbidol hydrochloride granules (0.1 g–0.2 g t.i.d.) and recombinant human interferon α 2b spray (0.083 mL t.i.d.)
All patients were divided into the treatment group (BRH group) or the control group (control group) at a 2:1 ratio. All participants were treated with antiviral drugs, including arbidol hydrochloride granules (0.1 g–0.2 g t.i.d.) and recombinant human interferon α 2b spray (0.083 mL t.i.d.), on the doctors’ discretion according to China’s Novel Coronavirus Pneumonia Diagnosis and Treatment Plan.
COVID-19 mild to moderate
Hospitalized patients with COVID-19 (≥ 18 years but ≤ 80 years) with confirmed or clinically suspected mild or moderatecoronavirus pneumonia (COVID-19), based on China’s Novel Coronavirus Pneumonia Diagnosis and Treatment Plan.
Open-label.
Single center, The Second Affiliated Hospital of Wenzhou Medical University, Zhejiang, China.
Clinical recovery was defined as clinical symptoms (fever and respiratory symptoms) returning to normal over 48 hours. Disease deterioration was defined as the presence of respiratory distress, respiratory rate ≥ 30 times/minute, oxygen saturation ≤ 93% in the resting state, and oxygenation index ≤ 300 mmHg.
Ensitrelvir (XOCOVA) (n=-9) vs. placebo (n=-9)
randomized controlled trial
ensitrelvir 125 mg or 250 mg
loading dose of ensitrelvir on day1 (375 mg for the 125 mg group and 750 mg for the 250 mg group), followed by the maintenance dose (125 mg for the 125 mg group and 250 mg for the 250 mg group) on days 2 through 5 without dose modification
placebo
COVID-19 mild to moderate
A majority of the patients in the ITT population had been vaccinated (ensitrelvir 125 mg, 14 [87.5%]; ensitrelvir 250 mg, 12 [85.7%]; and placebo, 123 12 [70.6%])
double blind
japan, 56 centers
favipiravir (n=193) vs. lopinavir/ritonavir (n=187)
randomized controlled trial
favipiravir
Favipiravir 1600 mg stat and then 600 mg every 8 h plus hydroxychloroquine 200 mg twice a day for 1 week.
lopinavir/ritonavir
single dose of hydroxychloroquine 400 mg followed by 100 400 Lopinavir/Ritonavir twice a day for 1 week
Later on, during the trial (31 May 2020), in light of emerging evidence, daily hydroxychloroquine in the Favipiravir group was reduced to a single dose of 400 mg as in control group
COVID-19 mild to moderate
open-label
20 centres, Iran
favipiravir (n=107) vs. placebo (n=49)
randomized controlled trial
Favipiravir
1800 mg twice a day on Day 1, followed by 800 mg twice a day for up to 13 days.
placebo
1:2 ratio. Seven patients in the placebo group were switched to treatment with favipiravir during Days 2–8 due to a lack of efficacy.
COVID-19 mild to moderate
Single blind.
Japan
Improvement was defined as follows:(1) improvement in temperature was defined as axillary temperature falling to =< 37.4 C and remaining at =< 37.4 C for at least 24 h (temperature recordings taken within 4 h after use ofan antipyretic were excluded); (2) improvement in SpO2 was defined as SpO2 remaining >= 96%for at least 24 h without the use of oxygen therapy; (3) improvement on chest imaging was defined as improvement in chest imaging findings taken at least 24 h after the previous image judged to be the worst; and (4) recovery to SARS-CoV-2-negative was defined as two consecutive negative results on qualitative tests by nucleic acid amplification separated by at least 24 h.
favipiravir (n=112) vs. standard of care (n=56)
randomized controlled trial
favipiravir
1800 mg BID on day 1, followed by 800 mg BID for up to9 days)
standard of care
umifenovir intranasal interferon alpha-2b, orhydroxychloroquine) for up to 10 days
COVID-19 mild to moderate
open label
10 centres, Russia
favipiravir (n=125) vs. standard of care (n=129)
randomized controlled trial
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
favipiravir (n=50) vs. standard of care (n=50)
randomized controlled trial
favipiravir
3200 mg (1600 mg 12 hourly) loading dose on day-1 followed by 1200 mg maintenance dose (600 mg 12 hourly daily) on day-2 to day-10
standard of care
oseltamivir 75 mg 12 hourly for 5-10 days and hydroxychloroquine 400mg 12 hourly day -1 followed by 200mg 12 hourly daily on day- 2 to day-5-10
COVID-19 mild to moderate
open label, randomized
2 centres, Egypt
favipiravir (n=75) vs. standard of care (n=75)
randomized controlled trial
favipiravir
3,600 mg (1,800 mg BID) (Day 1) 1,600 mg (800 mg BID) (Day 2 or later) for up to maximum of 14 days
sandard of care
Drugs thought to have antiviral activity against SARS CoV2 (including hydroxychloroquine) were prohibited
COVID-19 mild to moderate
open label
12 centres, India
Clinical cure was based on clinician assessment and defined as recovery of fever (axillary temperature ≤97.8°F), respiratory rate of ≤20 breaths/minute, oxygen saturation ≥98% without oxygen supplementation (which was later revised to align with the discharge criterion of ≥95% oxygen saturation issued by the Indian Ministry of Health prior to the start of the study), and cough relief (mild or no cough) maintained for ≥72 hours.
favipiravir (n=20) vs. standard of care (n=20)
randomized controlled trial
favipiravir
Favipiravir 1600 mg twice a day (BID) on Day 1 followed by 600 mg BID on Days 2-14 (1600/600 mg), or Favipiravir 1800 mg BID on Day 1 followed by 800 mg BID on Days 2-14 (1800/800 mg)
standard of care
COVID-19 mild to moderate
open label
6 centres, Russia
adaptative phase II/III3 arms : favipiravir low dose, or favipiravir high dose or SOC
favipiravir (n=100) vs. standard of care (n=100)
randomized controlled trial
favipiravir
1600 mg 2 times a day; on days 2-14 of treatment - 600 mg 2 times a day
standard of care
COVID-19 mild to moderate
open label
5 centres, Russia
Rate of clinical status improvement by categorical ordinal scale of clinical status improvement by 2 or more categories by Day 10 WHO Ordinal Scale for Clinical Improvement (WHO-OSCI), 0 - uninfected (There are no clinical and virological signs of infection), 8 - dead, higher scores mean a worse outcome
Article published in Russian. Results extracted from clinicaltrials.gov.
favipiravir plus interferon (n=44) vs. standard of care (n=45)
randomized controlled trial
favipiravir with interferon beta-1b by inhalation aerosol
favipiravir : 1600 mg (Day 1) followed by 600mg twice a day for a maximum of 10 daysinterferon beta-1 : 8million IU (0.25µg) twice a day for 5 days (through nebulization)
standard of care
HCQ 400 mg twice per day on the day 1, then 200 mg twice per day for 7 days
COVID-19 mild to moderate
open label
1 center, Oman
200 patients needed; due to logistical and financial constraints, only a total of 89 COVID-19 patients were enrolled into the study
hydroxychloroquine (n=221) vs. standard of care (n=227)
randomized controlled trial
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
ivermectin (n=12) vs. placebo (n=12)
randomized controlled trial
ivermectin
400 mcg/kg, single dose
placebo
COVID-19 mild to moderate
double bliind
1 center, Spain
ivermectin (n=57) vs. placebo (n=58)
randomized controlled trial
Ivermectin
ivermectin 12 mg on day 1 and day 2
Placebo
COVID-19 mild to moderate
All patients above the age of 18 admitted with a diagnosis of COVID -19 (on the basis of a positive RT PCR or Rapid Antigen Test report) at AIIMS, Patna, India with mild or moderate disease as defined by the ministry of health and family welfare guidelines and not meeting any of the exclusion criteria were considered eligible for the study. The exclusion criteria were: known allergy to or adverse drug reaction with Ivermectin; unwillingness or inability to provide consent to participate in the study; prior use of ivermectin during the course of this illness; pregnancy and lactation.
Double-blind.
Single center, tertiary care dedicated COVID-19 hospital in Bihar, India.
ivermectin (n=241) vs. standard of care (n=249)
randomized controlled trial
oral ivermectin, 0.4 mg/kg body weight daily for 5 days, plus standard of care
standard of care alone
symptomatic therapy and monitoring for signs of early deterioration based on clinical findings, laboratory test results, and chest imaging.
COVID-19 mild to moderate
open-label
Malaysia
ivermectin (n=30) vs. standard of care (n=15)
randomized controlled trial
Ivermectin
Standard of care plus oral ivermectin at 0.6 mg/kg/day for 5 days.
Standard of care
All patients in both groups received standard of care.
COVID-19 mild to moderate
Eligibility criteria included COVID-19 symptoms onset ≤ 5 days at recruitment, absence of use of drugs with potentialactivity against SARS-CoV-2 and available in Argentina during the trial (hydroxychloroquine, chloroquine, lopinavir and azithromycin); and those drugs were not permitted during the first week of the trial.
Open-label.
4 hospitals in the metropolitan area of Buenos Aires, Argentina.
ivermectin (n=35) vs. standard of care (n=38)
randomized controlled trial
Ivermectin
Single dose of 0.2 mg/kg
Standard of care
Standard drugs of the national protocol are used.
All patients in both groups received supportive medical treatment for COVID-19 according to the national protocols of Iran at the time of this study (hydroxychloroquine and/or lopinavir/ritonavir).
COVID-19 mild to moderate
The diagnostic criteria for COVID-19 included any of the following: (1) positive result on COVID-19 reverse-transcription polymerase chain reaction; (2) clinical symptoms of COVID-19, with a history of contact with a patient with COVID-19; and/or (3) abnormalities on chest computed tomography (CT) compatible with COVID19 (ground-glass opacity, halo sign, reversed halo sign, and patchy infiltration).
Double-blind.
2 centers in Mazandaran, Iran.
Clinical improvement after baseline was defined as resolving a patient’s baseline status on persistent and continuous cough (persistent cough for >1 hour, or ≥3 coughing episodes in 24 hours, that interferes with activities of daily living and the ability to work) and tachypnea in addition to increasing oxygen saturation to >94%.
ivermectin plus doxycycline (n=200) vs. standard of care (n=200)
randomized controlled trial
Ivermectin and Doxycycline
Ivermectin 6 mg, 2 tab stat and Doxycycline 100 mg twice daily for 5 days
standard of care
COVID-19 mild to moderate
double blind
1 center, Bangladesh
lopinavir/ritonavir (n=21) vs. standard of care (n=7)
randomized controlled trial
Lopinavir-ritonavir
Lopinavir (200mg) boosted by ritonavir (50mg) (oral, q12h, 500 mg each time for 7-14 days) monotherapy
Standard of care.
No antiviral medication. Supportive care and effective oxygen therapy if in need.
3 arms: lopinavir/ritonavir (n=21), arbidol=umifénovir (n=16) and standard of care (n=7).Standard of care in both groups.
COVID-19 mild to moderate
Open-label
China, single center
lopinavir/ritonavir, ribavirin and interferon beta-1b (n=86) vs. lopinavir/ritonavir (n=41)
randomized controlled trial
Interferon beta-1b, lopinavir–ritonavir, and ribavirin
14-day combination of lopinavir 400 mg and ritonavir 100 mg every 12 h, ribavirin 400 mg every 12 h, and three doses of 8 million international units of interferon beta-1b on alternate days
lopinavir–ritonavir
14 days of lopinavir 400 mg and ritonavir 100 mg every 12 h
COVID-19 mild to moderate
age at least 18 years, a national early warning score 2 (NEWS2) of at least 1, and symptom duration of 14 days or less upon recruitment
Open-label.
Hong Kong, 6 centers
phase 2, intention-to-treat population
there is a discrepancy between the main objective of the study mentioned in clinicaltrials.gov which refers to mortality and the main endpoint presented in the publication. The sample size calculation also refers to mortality. However, at the date of initial registration (Feb. 19), the primary endpoint was already PCR-negative conversion, which allows to rule out result-driven change.
remdesivir (n=200) vs. remdesivir (n=197)
randomized controlled trial
Remdesivir (5 days)
Intravenous remdesivir 200 mg on day 1, followed by 100 mg of remdesivir once daily for the subsequent 4 days.
Remdesivir (10 days)
Intravenous remdesivir 200 mg on day 1, followed by 100 mg of remdesivir once daily for the subsequent 9 days.
Both treatment groups continued supportive therapy at the discretion of the investigator throughout the duration of the trial.
COVID-19 mild to moderate
Patients who were receiving mechanical ventilation and extracorporeal membrane oxygenation (ECMO) at screening were excluded, as were patients with signs of multiorgan failure.
Open-label.
55 hospitals in the United States, Italy, Spain, Germany, Hong Kong, Singapore, South Korea, Taiwan.
7-point ordinal scale consisting of the following categories: 1, death; 2, hospitalized, receiving invasive mechanical ventilation or ECMO; 3, hospitalized, receiving noninvasive ventilation or high-flow oxygen devices; 4, hospitalized, requiring low-flow supplementaloxygen; 5, hospitalized, not requiring supplemental oxygen but receiving ongoing medical care (related or not related to Covid-19); 6, hospitalized, requiring neither supplemental oxygen nor ongoing medical care (other than that specified in the protocol for remdesivir administration); and 7, not hospitalized.
remdesivir (n=199) vs. standard of care (n=200)
randomized controlled trial
5-day course of remdesivir
200 mg of remdesivir intravenously on day 1, followed by 100 mg of remdesivir once daily for the subsequent days, infused over 30 to 60 minutes.
Standard care
Treatment with SOC according to local practice.
3 arms study : RDV 5 days, RDV 10 days, standard of care. All participants will continue to receive SOC therapy according to local guidelines. Participants randomized to receive RDV will receive thisin addition to their other care. Remdesivir treatment was to be discontinued in any patient experiencing severe elevations in liver enzymes or decreases in estimated creatinine clearance to less than 30 mL/min.
COVID-19 mild to moderate
Participants with COVID-19 confirmed by polymerase chain reaction (PCR) who meet the following criteria: Willing and able to provide written informed consent (age ≥18) or assent (age ≥12 to <18, where locally and nationally approved) prior to performing study procedures, Hospitalized and requiring medical care for COVID-19, SpO2 > 94% on room air at screening, Radiographic evidence of pulmonary infiltrates.
Open-label.
Multicenter: 105 hospitals in the United States, Europe, and Asia.
7-point ordinal scale consisting of the following categories: 1, death; 2, hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation; 3, hospitalized, requiringnoninvasive ventilation or use of high-flow oxygen devices; 4, hospitalized, requiring low-flow supplemental oxygen; 5, hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (related or not to COVID-19); 6, hospitalized, not requiring supplemental oxygen orongoing medical care; and 7, not hospitalized. Differences between remdesivir treatment groups and standard care were calculated usingproportional odds models and expressed as odds ratios. An odds ratio greater than 1 indicatesdifference in clinical status distribution toward category 7 for the remdesivir group vs thestandard care group.
remdesivir (n=197) vs. standard of care (n=200)
randomized controlled trial
Remdesivir (10 days)
200 mg of remdesivir intravenously on day 1, followed by 100 mg of remdesivir once daily for the 9 subsequent days, infused over 30 to 60 minutes.
Standard of care
Treatment with SOC according to local practice.
3 arms study : RDV 5 days, RDV 10 days, standard of care. All participants will continue to receive SOC therapy according to local guidelines. Participants randomized to receive RDV will receive thisin addition to their other care. Remdesivir treatment was to be discontinued in any patient experiencing severe elevations in liver enzymes or decreases in estimated creatinine clearance to less than 30 mL/min.
COVID-19 mild to moderate
Participants with COVID-19 confirmed by polymerase chain reaction (PCR) who meet the following criteria: Willing and able to provide written informed consent (age ≥18) or assent (age ≥12 to <18, where locally and nationally approved) prior to performing study procedures, Hospitalized and requiring medical care for COVID-19, SpO2 > 94% on room air at screening, Radiographic evidence of pulmonary infiltrates.
Open-label.
Multicenter: 105 hospitals in the United States, Europe, and Asia.
7-point ordinal scale consisting of the following categories: 1, death; 2, hospitalized, requiring invasive mechanical ventilation or extracorporeal membrane oxygenation; 3, hospitalized, requiringnoninvasive ventilation or use of high-flow oxygen devices; 4, hospitalized, requiring low-flow supplemental oxygen; 5, hospitalized, not requiring supplemental oxygen but requiring ongoing medical care (related or not to COVID-19); 6, hospitalized, not requiring supplemental oxygen orongoing medical care; and 7, not hospitalized. Differences between remdesivir treatment groups and standard care were calculated usingproportional odds models and expressed as odds ratios. An odds ratio greater than 1 indicatesdifference in clinical status distribution toward category 7 for the remdesivir group vs thestandard care group.
sofosbuvir and ledipasvir (n=45) vs. standard of care (n=45)
randomized controlled trial
Sofosbuvir/ledipasvir
SOF/LDP 400/90 mg daily for 10 days plus standard of care.
Standard of care
Standard of care alone.
In addition to the supportive care modalities, the standard of care according to the hospital protocol included hydroxychloroquine (HCQ 400 mg BD at first day then 200 mg BD for 7 days) plus atazanavir/ritonavir 300/100 mg daily for 7 days. Standard of care in both groups.
COVID-19 mild to moderate
Adult patients (≥18 years old) with highly suspected (according to the clinical signs/symptoms andimaging findings) or confirmed (a positive PCR of pharyngeal or nasopharyngeal samples) COVID-19 who were admitted to medical wards of the hospital, were included.
Open-label.
Single-center, Imam Khomeini Hospital Complex, Tehran, Iran.
Clinical response was defined as one order decline in disease category in the five category ordinal scale. The categories are: death (5), mechanical ventilation (4), non-invasive ventilation (3), oxygen mask or nasal cannula (2), discharge(1).
umifenovir (arbidol) (n=35) vs. lopinavir/ritonavir (n=34)
randomized controlled trial
Umifenovir
Arbidol (100mg) (oral, 200mg TID for 7-14 days)
Lopinavir/ritonavir
Lopinavir (200mg) boosted by ritonavir (50mg) (orally administed, twice daily, 500 mg, each time for 7-14 days).
3 arms : lopinavir/ritonavir; arbidol and standard care
COVID-19 mild to moderate
Open-label
China, single center
No deaths occurred.
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