Trial IRCT20200523047550N1
Publication Ghaderkhani S, Research Square, 2021 (preprint)
Dates: 2020-04-20 to 2020-06-04
Funding: Public/non profit (Tehran University of Medical Sciences and health services grant; Umifenovir was provided by the Center for Progress and Development (CPDI) of Iran Presidency)
Conflict of interest: No

Methods
RCT
Blinding: Unblinded
Location : Single center / Iran
Follow-up duration (days): 14
Inclusion criteria>=18 years; oral tolerance; written informed consent; diagnosis of mild to moderate COVID-19 infection (Adolescent or adult with clinical signs of pneumonia (fever, cough, dyspnoea, fast breathing) fatigue , anorexia , myalgias and Other nonspecic symptoms, such as sore throat, nasal congestion, headache, diarrhoea, nausea and vomiting, but should be without signs of severe pneumonia (including SpO2 ≥ 90% on room air, respiratory rate > 30 breaths/min; severe respiratory distress)
Exclusion criteriaAlanine aminotransferase (ALT) value greater than five times the normal range (normal value for ALT in blood ranges from 29 to 33 units per liter (IU/L) for males and 19 to 25 IU/L for females)
Interventions
Treatment
Hydroxychloroquine+Umifenovir
200 mg orally every 12 hours + 200 mg orally every 8 hours for 10 days
Control
Hydroxychloroquine ( / )
Participants
Randomized
56 participants (n1=28 / n2= 28)
Characteristics of participants
N=56
Mean age : NR
32 males
Severity : Mild: n=* / Moderate: n=*/ Severe: n=0 Critical: n=0
Primary outcome
In the register
Percentage of people improved with arbidol 5, 7 and 14 days after taking Arbidol
In the report
Survival of symptoms three days after onset illness
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated

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
*
General comment This study is pending contact with authors. No data relevant to the COVID-NMA were available in the report.
In addition to the pre-print article, the retrospectively registered study registry was used in data extraction and risk of bias assessment. This outpatient trial reported on COVID symptoms and drug side effects