Evaluating the effects of Adalimumab in patients with acute respiratory distress syndrome caused by COVID-19

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2020
INTERVENTION: Intervention 1: Intervention group: Patients in treatment group received single dose of adalimumab ampule (CinnoRA, CinnaGen), 40 mg subcutaneously with supportive treatments according to national guideline. Supportive treatment includes interferon b1a (Resigen) 44 microgram every other day for 3 doses + Lopinavir/Ritonavir 200‐50 mg (Hetero Labs Limited) 2 Tab twice daily for 7 days. Intervention 2: Control group: Patients in control group received supportive care according national guideline. Supportive treatment includes interferon b1a (Resigen) 44 microgram every other day for 3 doses + Lopinavir/Ritonavir 200‐50 mg (Hetero Labs Limited) 2 Tab twice daily for 7 days. CONDITION: COVID‐19 pneumonia. ; COVID‐19, virus identified U07.1 PRIMARY OUTCOME: 28 days mortality. Timepoint: From the first day of admission until 28 days. Method of measurement: Medical record. Clinical improvement (hospital discharge). Timepoint: Daily until discharge. Method of measurement: Medical record. Clinical improvement (length of time in which patient needs oxygen therapy). Timepoint: Daily until discharge. Method of measurement: Medical record. Need for mechanical ventilation. Timepoint: Daily until discharge. Method of measurement: Medical record. SECONDARY OUTCOME: Length of hospital stay. Timepoint: Daily until discharge. Method of measurement: Medical record. Lung radiological changes. Timepoint: First day of the study then at day 5. Method of measurement: Computed tomography. Number of days admitted to critical care unit. Timepoint: Daily until discharge. Method of measurement: Medical record. RT‐PCR result. Timepoint: First day of the study then at day 5. Method of measurement: Medical record. INCLUSION CRITERIA: Patients between 18 and 65 years old. Laboratory confirmed COVID‐19 (Corona Virus Disease‐19) with RT‐PCR (Real‐Time Polymerase Chain Reaction) or CT scan. Sever or critically ill patients. CRP rise two times the normal value. IL‐6 above 7 pg/ml. Signed the consent form
Epistemonikos ID: 46b61aa744ecf0fd707fe1dac6a123d5c51bf26d
First added on: Nov 11, 2020