The Efficacy of dimethyl fumarate in the treatment of patients with COVID-19

Phase 2

• Conditions: COVID-19.; COVID-19, virus identified; U07.1

• Registration Number: IRCT20201024049134N4
• Lead Sponsor: Babol University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 1 November 2021

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

Men and women of at least 18 years of age capable of providing informed consent
Confirmation of COVID-19 with RT-PCR
Need for hospitalization
No need for mechanical ventilation
No need to more than 10 L/min of supplemental oxygen by any device.
The patient must meet at least one of the following high-risk criteria: age 70 years or older, obesity (BMI = 30 kg/m2), diabetes mellitus, uncontrolled blood pressure (systolic blood pressure> 150 mm Hg), history of respiratory disease (Including asthma or COPD), history of heart failure, history of coronary artery disease, fever > 38.4°C in the last 48 hours, shortness of breath at the time of referral, Bicytopenia, Pancytopenia, or a combination of neutrophilia and lymphopenia

Exclusion Criteria

History of allergy to dimethyl fumarate
Use of dimethyl fumarate before current hospitalization
Patients more than 70 years of age with a history of any of the following in the last six months: Class III / IV Heart Failure Based on the New York Heart Association (NYHA) classification, Insulin-dependent diabetes, Angina pectoris, Malignancy
Uncontrolled bacterial, fungal, or viral infection (other than COVID-19).
Any history of receiving convalescent plasma therapy
Absolute neutrophil count (ANC) < 500
Platelets count < 50,000
Pregnant women or those intending to become pregnant
Breastfeeding women
AST or ALT > 5 times the upper limits of normal (ULN)
Estimated glomerular filtration rate (eGFR) < 30 ml/min in 1.73 m2 using MDRD equation

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
eed for mechanical ventilation. Timepoint: 30 days after the start of the intervention. Method of measurement: Examination of the patients by the research team.;Death. Timepoint: 30 days after the start of the intervention. Method of measurement: Examination of the patients by the research team.;Severely ill. Timepoint: 30 days after the start of the intervention. Method of measurement: Examination of the patients by the research team.

Secondary Outcome Measures

Name	Time	Method
Cessation of fever. Timepoint: 30 days after the start of the intervention. Method of measurement: Examination of the patients by the research team.;Improve ESR, CRP, and CBC test results. Timepoint: 30 days after the start of the intervention. Method of measurement: Interpretation of paraclinical tests' results.;Negative RT-PCR test. Timepoint: 30 days after the start of the intervention. Method of measurement: RT-PCR test.;Improve oxygen saturation. Timepoint: 30 days after the start of the intervention. Method of measurement: Pulse oximeter.;Improve pulmonary involvement on CT scan. Timepoint: 30 days after the start of the intervention. Method of measurement: Chest CT scan.