Trial IRCT20210214050350N1
Publication Kalantari S, J Med Virol, 2021 (published paper)
Dates: 2021-01-30 to 2021-02-14
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): 10
Inclusion criteriaConfirmed moderate to severe COVID-19 infection (in accordance with published national guidelines with criteria consisting of three or more of the following conditions: (1) cough, (2) weakness, (3) fever of ≥38.5°C, (4) intense fatigue, (5) myalgia, (6) sore throat, (7) dyspnea, (8) low appetite/Diarrhea/nausea, and (9) decreased awareness. Additionally, COVID-19 would also be confirmed if the patient had one or more of the following disease characteristics: (1) oxygen saturation value of less than 93%, (2) disease confirmation based on chest imaging results, and (3) a respiratory rate greater than 24 breaths per minute.); needed hospitalization
Exclusion criteriaNegative SARS-CoV-2 RT-PCR test result
Interventions
Treatment
Atazanavir+Ritonavir+Dolutegravir+Hydroxychloroquine
Atazanavir 300 mg/Ritonavir 100 mg orally once a day.
Dolutegravir 500 mg orally once a day
Hydroxychloroquine 400 mg twice a day orally on day 1 and then 200 mg twice a day on days 2-10
Control
Hydroxychloroquine+Lopinavir+Ritonavir ( / )
Participants
Randomized
* participants (n1=* / n2= *)
Characteristics of participants
N=*
Mean age : NR
28 males
Severity : Mild: n=* / Moderate: n=*/ Severe: n=* Critical: n=0
Primary outcome
In the register
1) Death during treatment; 2) ICU admission during treatment; 3) Intubation during treatment
In the report
NR
Documents
available

Protocol

NR

Statistical plan

NR

Data-sharing stated
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 In addition to the published article, the retrospective trial registry was used in data extraction and risk of bias assessment. Neither protocol nor statistical analysis plan was available. The target sample size was achieved. The study was registered as a non-randmized study while recruiting, however, the publication reports that the study was randomized. There is no change from the trial registration in the intervention and control treatments. All outcomes from the registry are reported in the paper (mortality, ICU admission, intubation) but follow-up and number of randomized and analyzed participants per group were unclear. Consequently, no outcome data were collected from the publication pending contact with authors.