click on circles to display study description...

Solaymani-Dodaran, 2021 IRCT20200318046812N1

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

Shinkai, 2021 JapicCTI-205238

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.

AVIFAVIR, 2020 NCT04434248

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

NCT04542694, 2020 NCT04542694

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.

Ruzhentsova T, 2020 NCT04501783

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

Dabbous HM, 2020 NCT04349241

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

FACCT Trial, 2021 NCT04392973

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

Udwadia, 2020 CTRI/2020/05/025114

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.