The Efficacy of Famotidine in improvement of outcomes in Hospitalized COVID-19 Patients: A structured summary of a study protocol for a randomised controlled trial

• Published in: Current controlled trials in cardiovascular medicine 2020-10, Vol.21 (1), p.848-3, Article 848
• Main Authors: Samimagham, Hamid Reza, Hassani Azad, Mehdi, Haddad, Maryam, Arabi, Mohsen, Hooshyar, Dariush, KazemiJahromi, Mitra
• Format: Article
• Language: English
• Subjects: Betacoronavirus - drug effects; Betacoronavirus - genetics; Case-Control Studies; Clinical Protocols; Codes; Coronavirus Infections - drug therapy; Coronavirus Infections - epidemiology; Coronavirus Infections - virology; Coronaviruses; COVID-19; Creatinine; Dehydrogenases; Drug therapy; Efficacy; Famotidine; Famotidine - adverse effects; Famotidine - therapeutic use; Histamine H2 Antagonists - adverse effects; Histamine H2 Antagonists - therapeutic use; Hospital patients; Hospitalization - trends; Hospitalized; Humans; Intervention; Iran - epidemiology; Letter; Outcome Assessment, Health Care - trends; Pandemics; Patient Discharge; Placebos - administration & dosage; Pneumonia, Viral - drug therapy; Pneumonia, Viral - epidemiology; Pneumonia, Viral - virology; protocol; Randomised controlled trial; SARS-CoV-2; Severe acute respiratory syndrome coronavirus 2; Testing
• ISSN: 1745-6215; 1745-6215
• DOI: 10.1186/s13063-020-04773-6

This study aims to investigate the effect of Famotidine on the recovery process of COVID-19 patients. This phase III randomized clinical trial was designed with two parallel arms, placebo-controlled, single-blind, and concealed allocation. All COVID-19 patients admitted to Shahid Mohammadi Hospital in Bandar Abbas whose PCR test results are positive for SARS-Cov-2 and sign the written consent of the study are included in the study and immunocompromised patients, end-stage renal disease, moderate renal failure (clearance Creatinine 30 to 50 ml/min) or stage 4 severe chronic kidney disease or need for dialysis (creatinine clearance lesser than 30 ml/min), history of liver disease, hepatitis C infection or alcoholism, Glucose 6 phosphate dehydrogenase deficiency(G6PD), the ratio of Alanine transaminase to Aspartate transaminase 5 times above the normal limit, history or evidence of long QT segment on Electrocardiogram, psoriasis or porphyria, pregnancy, use of oral contraceptives, Dasatinib, Neratinib, Ozanimod, Pazopanib, Rilpivirine, Siponimod and/or Tizanidine and allergies to any study drug are excluded. Intervention group receives standard pharmacotherapy according to the treatment protocols of the National Committee of COVID-19 and oral famotidine 160 mg (Manufactured by Chemidarou Pharmaceutical Company) four times a day until the day of discharge, for a maximum of fourteen days. Comparator group receives standard drug therapy according to the treatment protocols of the National Committee of COVID-19 and placebo in the same dosage. Patients' temperature, respiration rate, oxygen saturation, lung infiltration, lactate dehydrogenase and complete blood count were measured at the baseline (before the intervention) and on day 14 after the intervention or on the discharge day. The person who has no role in admitting patients and assigning patients to random codes preparing random sequences using online tools and by permuted block randomization method. Eligibility criteria are monitored by the person responsible for admitting patients. Codes in a random sequence are assigned to patients by the treatment team without knowing that each code is in the intervention or comparator group. Patient codes are then matched to randomly generated sequence information for interventions. All participants are unaware of which group of this study they are in and after grouping patients in the groups, Patients receive Famotidine in the treatment group and receive a placebo in