Famotidine and COVID-19

• Register: IRCT
• Last refreshed on: 7 September 2020
• Main ID: IRCT20200509047364N2
• Date of registration: 2020-08-17
• Prospective Registration: No
• Primary sponsor: Bandare-abbas University of Medical Sciences
• Public title: Famotidine and COVID-19
• Scientific title: The effect of Famotidine on the improvement of patients with COVID-19
• Date of first enrolment: 2020-06-21
• Target sample size: 20
• Recruitment status: Recruiting
• URL: http://en.irct.ir/trial/49657
• Study type: interventional
• Study design: Randomization: Randomized, Blinding: Single blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Before assigning groups to individuals eligible to participate in the study, informed consent is completed for grouping individuals. the person who has no role in admitting patients and assigning patients to random codes preparing random sequences using online tools (https://www.sealedenvelope.com/) and by permuted block randomization method. Individualized random allocation is done in blocks with sizes 2 and 4, and without stratification. 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 placebo group. Patient codes are then matched to randomly generated sequence information for interventions. (randomization concealment is done by the treatment team without informing the person resp
• Phase: 3

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Dariush Hooshyar
• Affiliation: Bandare-abbas University of Medical Sciences

• Name: Dr. Mitra Kazemijahromi
• Affiliation: Bandare-abbas University of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: All COVID-19 patients whose disease has been confirmed by the PCR test for SARS-Cov-2.
Signing the written consent of the study participant.
Exclusion criteria: All Immunocompromised patients
End stage renal disease
Moderate renal insufficiency (creatinine clearance 30-50 mL/min)
stage 4 sever chronic kidney disease
requiring dialysis (i.e creatinine clearance <30 mL/min)
History of hepatic disease
History of hepatitis C infection
History of alcoholism
G-6-PD (glucose-6-phosphate dehydrogenase deficiency)
ALT/AST >5 times the upper limit of normal.
History of or evidence of QT prolongation on ECG examination
History of psoriasis
History of porphyria
Pregnancy
Use of oral contraceptive pills (OCP)
Concomitant use of Dasatinib
Concomitant use of Neratinib
Concomitant use of Ozanimod
Concomitant use of Pazopanib
Concomitant use of Rilpivirine
Concomitant use of Siponimod
Concomitant use of Tizanidine
Allergy to any study medication

Age minimum: no limit
Age maximum: no limit
Gender: Both

Health Condition(s) or Problem(s) studied

Laboratory confirmed COVID-19.
COVID-19, virus identified

U07.1

Intervention(s)

Intervention 1: Intervention group: Group A 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. Vital signs of patients are also checked at regular intervals and frequently. Standard pharmacotherapy according to the treatment protocols of the National Committee of COVID-19 includes Hydroxychloroquine / Chloroquine Phosphate: Hydroxychloroquine sulfate tablets 200 mg or chloroquine phosphate tablets 250 mg (equivalent to 150 mg base dose) 2 tablets every 12 hours on the first day and then one tablet every 12 hours for at least 7 days and up to 14 days. One of the following medications at the discretion and diagnosis of the treating physician: kaletra tablets (Lopinavir / Ritonavir) 50/200 mg every 12 hours 2 pieces after meals for at least 7 days and a maximum of 14 days. Tablets (Atazanavir / Ritonavir) 300/100 One tablet daily with food or Atazanavir 400 mg daily for at least 7 days and up to 14 days. Intervention 2: Control group: Group B receives standard drug therapy according to the treatment protocols of the National Committee COVID-19 and placebo in the form of oral tablets four times a day, daily until patients are discharged, for a maximum of fourteen days. Standard pharmacotherapy according to the treatment protocols of the National Committee of COVID-19 includes Hydroxychloroquine / Chloroquine Phosphate: Hydroxychloroquine sulfate tablets 200 mg or chloroquine phosphate tablets 250 mg (equivalent to 150 mg base dose) 2 tablets every 12 hours on the first da

Primary Outcome(s)

Lymphocyte count. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pathobiology laboratory.

Lactate Dehydrogenase(LDH) level's. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pathobiology laboratory.

Lung infiltration status. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Chest X-ray.

C-reactive protein(CRP) level's. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pathobiology laboratory.

Oxygen saturation state. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pulse oximeter.

Platelet count. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pathobiology laboratory.

Respiratory rate. Timepoint: At the beginning of the study (before the intervention) and day 14 after the intervention or the day of patient's discharge. Method of measurement: Pulse oximeter.

Secondary Outcome(s)

Patient temperature status. Timepoint: At the beginning of the study (before the intervention), days 1 to 14 of the intervention or the time of the patient's discharge. Method of measurement: Digital thermometer.

Length of hospitalization. Timepoint: At the beginning of the study (before the intervention), days 1 to 14 of the intervention or the time of the patient's discharge. Method of measurement: Record patient information.

Length of Intensive Care Unit admission. Timepoint: At the beginning of the study (before the intervention), days 1 to 14 of the intervention or the time of the patient's discharge. Method of measurement: Record patient information.

Source(s) of Monetary Support

Bandare-abbas University of Medical Sciences

Ethics review

Status: Approved
Approval date: 02/08/2020
Contact:

Ethics committee of Hormozgan University of Medical Sciences