COVID-19 trials registries data warehouse

http://en.irct.ir/trial/59456

Reza Ghadimi

rezaghadimi@yahoo.com

2021-10-21

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

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

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

2

Babol University of Medical Sciences

18

100

Iran

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

30

Need for mechanical ventilation Death Severely ill

Phase 2/Phase 3

[{"arm_notes": "", "treatment_id": 407, "treatment_name": "Dimethyl fumarate", "treatment_type": "Immunosuppressants", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]