Covid-19 Living Data

Trial IRCT20180725040596N2
Publication Nojomi M, BMC Infect Dis. (2020) (published paper)
Dates: 2020-04-20 to 2020-06-18
Funding: Public/non profit (Iran University of Medical Sciences)
Conflict of interest: No

Methods
	RCT Blinding: Unblinded
	Location : Single center / Iran Follow-up duration (days): 30
Inclusion criteria	Non-pregnant women and men aged 18 years old or more with definite diagnosis of COVID-19 by RT-PCR or CT scan imaging (pneumonia), and oxygen saturation of 94% or less. The findings of CT were described as bilateral lung opacities and lobular and sub segmental areas of consolidation
Exclusion criteria	History of allergy to Arbidol class of drugs, abnormal liver or renal function, abnormal blood coagulation, Arbidol was used before inclusion, women who are nursing or pregnant, and patients with severe heart disease
Interventions
	Treatment HCQ+LPV/r Hydroxychloroquine: 400 mg on first day. Lopinavir/ritonavir: 400 mg twice a day for 7 to 14 days
	Control HCQ+Umif Hydroxychloroquine: 400 mg twice on first day Umifenovir: 200 mg orally 3 times a day for 7 to 14 days
Participants
	Randomized participants : HCQ+Umif=50 HCQ+LPV/r=50
	Characteristics of participants N= 100 Mean age : NR 60 males Severity : Mild: n=* / Moderate: n=* / Severe: n=* Critical: n=0 Number of vaccinated participants: NR
Primary outcome
	In the register Fever, Complete blood count, C-reactive protein, chest CT Scan view symptoms, Measurement of blood oxygen saturation and no adjuvant oxygen therapy, Hospital admission days (NB - duration of hospitalisation was added as a primary outcome after study
	In the report Hospitalization duration and clinical improvement 7 days after admission
Documents available	Protocol NR Statistical plan NR Data-sharing willing stated in the publication: Yes
Risk of bias Overall The overall risk of bias reported in the table corresponds to the highest risk of bias for the outcomes assessed for the systematic review	Some concerns
General comment	In addition to the pre-print article, the study registry was used in data extraction and risk of bias assessment. The target sample size specified in the registry was achieved. Several changes were made to the trial registration. Chest CT scan was added as an outcome during the conduct of the study. After study completion, changes were made to primary and secondary outcomes, including the addition of the primary outcome as reported in the pre-print article. During the conduct of the study the treatments in the trial registration were changed: the dosage of Umifenovir was increased; the duration of both study treatments was extended; the duration of Hydroxychloroquine treatment was extended in the Umifenovir arm but not in the Lopinavir-ritonavir arm.