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IRCT20151227025726N23 IRCT 2020-11-10 Shahid Beheshti University of Medical Sciences Evaluating the effects of Adalimumab in patients with acute respiratory distress syndrome caused by COVID-19 Evaluating the efficacy and safety of Adalimumab in patients with acute respiratory distress syndrome caused by COVID-19 2020-08-06 anticipated 60 Complete https://irct.ir/trial/51473 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization method was used in this study. Ten blocks including six patients generated with online website (www.sealedenvelope.com/simple-randomiser/v1/lists). In each block, three patients will be assigned to adalimumab group and three patients will be assigned to control group. 2-3 COVID-19 pneumonia. 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. Yes - There is a plan to make this available What will be shared: All potential data can be shared after blinding When: Six months after publishing the results To whom: Researchers working in academic institutions Conditions: For research purposes and meta-analysis studies Where to obtain: Dr. farzaneh Dastan, Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran How to obtain: Official letter to the researchers through Email (fzh.dastan@gmail.com). Comments:
public Atefeh Fakharian
Dr. Masih Daneshvari Hospital, Daar-Abad, Niavaran
Tehran Iran (Islamic Republic of) 19569-44413 +98 21 2712 2066 Atefeh.fakharian7@gmail.com Shahid Beheshti University of Medical Sciences scientific Farzaneh Dastan
Faculty of Pharmacy, Shahid Beheshti University of Medical Sciences, Intersection of Niyayesh Highway, Valieasr St.
Tehran Iran (Islamic Republic of) 1991953381 +98 21 8820 0118 f_dastan@sbmu.ac.ir Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) 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 18 years 65 years Both Acute or chronic renal failure (creatinine rise above 3 mg/dL during the last 48 hours or GFR les than 30 mL/min) Liver failure (LFT rise five times the upper limit or three time rise in symptomatic patients or Child Pugh C or D) Allergic reaction while injecting adalimimab with severe extravasation or anaphylactic reaction. Patient with mild disease Pregnancy or breastfeeding Patients with IL-6 below 7 pg/ml Patient with latent or active TB or any other active infection History of active pectic ulcer Receiving drugs effective on interleukin or TNF alpha History of malignancy Patient with heart failure U07.1 COVID-19, virus identified Treatment - Drugs Treatment - Drugs 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. 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. 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. 28 days mortality. Timepoint: From the first day of admission until 28 days. Method of measurement: Medical record. Number of days admitted to critical care unit. Timepoint: Daily until discharge. Method of measurement: Medical record. 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. RT-PCR result. Timepoint: First day of the study then at day 5. Method of measurement: Medical record. Shahid Beheshti University of Medical Sciences Approved 2020-08-05 Ethics Committe of Shahid Beheshti University of Medical Sciences 3 rd floor, School of Medicine, Evin St, Shahid Chamran Highway Tehran Tehran Iran (Islamic Republic of)