Covid-19 Living Data

Trial IRCT20200509047364N2
Publication Samimagham HR, Research Square, 2021 (preprint)

Funding: Public/non profit (Bandare-abbas University of Medical Sciences)
Conflict of interest: No

Methods
	RCT Blinding: single blinding
	Location : Single center / Iran Follow-up duration (days): 14
Inclusion criteria	COVID-19 infection confirmed by a PCR test for SARS-Cov-2; written informed consent to participate in the study.
Exclusion criteria	Suffering from immunodeficiency; end-stage renal disease, moderate renal failure (creatinine clearance 30–50 ml/min), stage 4 severe chronic kidney disease, dialysis (creatinine clearance < 30 ml/min); history of liver disease, history of hepatitis C infection; history of alcoholism, Glucose-6-Phosphate Dehydrogenase Deficiency (G6PD); ALT/AST > 5 times normal limit; history or evidence of prolonged QT on ECG; history of psoriasis; history of porphyria; pregnancy; taking oral contraceptive pills (OCPs); taking Dasatinib, Neratinib, Ozanimod, Pazopanib, Rilpivirine, Siponimod or Tizanidine; allergy to any medications used in this clinical trial.
Interventions
	Treatment Famotidine 160 mg orally four times a day until discharge or up to 14 days.
	Control Standard care ( / ) Definition of Standard care: Standard pharmacotherapy according to the National Committee of COVID-19 treatment protocols included: (i) Hydroxychloroquine/chloroquine phosphate: Hydroxychloroquine sulfate tablets 200 mg or chloroquine phosphate tablets 250 mg (equivalent to 150 mg base amount); 2 tablets every 12 hours on the first day and then 1 tablet every 12 hours for at least 7 days and up to 14 days. (ii) One of the following medications at the discretion of the treating physician: Kaletra tablets (lopinavir/ritonavir) 200/50 mg; 2 tablets every 12 hours after meals for at least 7 days and up to 14 days. (iii) Atazanavir/Ritonavir 300/100 tablet: 1 tablet a day with food; or Atazanavir 400 mg daily for a minimum of 7 days and a maximum of 14 days.
Participants
	Randomized 20 participants (n₁=10 / n₂= 10)
	Characteristics of participants N=20 Mean age : 47.5 13 males Severity : Mild: n=* / Moderate: n=/ Severe: n= Critical: n=*
Primary outcome
	In the register Respiratory rate, oxygen saturation state, lung infiltration status, lactate Dehydrogenase(LDH) level's, C-reactive protein(CRP) level's, lymphocyte count, platelet count.
	In the report Patients’ temperature, respiration rate, oxygen saturation, lung infiltration, lactate dehydrogenase and complete blood count.
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	Some concerns
General comment	In addition to the pre-print article, the retrospective trial registry was used in data extraction and assessment of risk of bias. Neither protocol nor statistical analysis plan was available. The study achieved the target sample size specified in the trial registry. There is no change from the trial registration in the intervention and control treatments. The registry primary outcomes reflect the reported primary outcomes; however, mortality was not mentioned in the registry.