COVID-19 trials registries data warehouse

http://en.irct.ir/trial/51499

Ali Rakei

a.rakei@cobeldarou.com

2020-10-26

Completed

RCT

Randomized

Parallel

Open label

multi-center

Treatment

Patients with mild to moderate COVID-19 symptoms (According to the national guidance definitions) with positive PCR test for COVID-19 At least 18 years old Less than 10 days from the onset of symptoms

History of liver disorders (specifically active liver disorders and liver dysfunction included: ALT/AST > 1.5 ULN and ALP > 2.5 ULN and total Bilirubin>1.25 ULN) Allergy to Favipiravir or its ingredients Pregnancy and lactation History of gastrointestinal(GI) disorders such as GI bleeding or GI inflammatory diseases or history of GI surgery that intervene in the Favipiravir absorption process History of active or latent tuberculosis Active infection other than COVID-19 Abnormal metabolism of uric acid/ Gout Abnormal test results in the screening stage that need more clinical assessments Participation in any type of clinical trials in the last 30 days Any psychological disorders that affects patient compliance of the study protocol Any disease or disorder that investigators believed might put participants in an excess risk, if they were included or history of allergy to any antiviral nocleoside-analog drugs with viral RNA polymerase inhibition mechanism Active HBV, HCV HIV or any other known immunological disorders or using immunosuppressive drugs

2

Dr. Abidi pharmacutical Co.

18

100

Iran

Mild/moderate disease at enrollment

2: Mild/moderate disease at enrollment

126

Turning PCR test result into negative Time to recovery of symptoms(fever and cough) Symptoms recovery(fever and cough)

Phase 3

[{"arm_notes": "", "treatment_id": 504, "treatment_name": "Favipiravir", "treatment_type": "Antivirals", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]