COVID-19. COVID-19, virus identified
Conditions
Interventions
Intervention 1: Control group: Patients in this group receive placebo capsules (capsules containing wheat flour) daily for 5 days (a total of 5 capsules per patient). Also, in this group, in addition
Sponsors
Babol University of Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
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
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) 5 times the upper limits of normal (ULN) Estimated glomerular filtration rate (eGFR) < 30 ml/min in 1.73 m2 using MDRD equation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Need 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
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMohammad Barary
Babol University of Medical Sciences
Outcome results
None listed