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IRCT20170207032444N3 IRCT 2020-04-17 Esfahan University of Medical Sciences Thalidomide in COVID19 The efficacy and safety of Thalidomide in severe Covid19 pneumonia: Arandomized controlled clinical trial 2020-04-15 anticipated 60 Complete https://irct.ir/trial/47119 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be done. We use random allocation service for randomization. There is no allocation concealment. 3 COVID19. Intervention 1: Intervention group: Tab Thalidomide ( Talidex) from Alan pharmaceuticals, daily until 14 days. Both case and control group will be received hydroxychloroquine tablet 100 mg BD, methylprednisolon 50 mg IV, antibiotic depend on physician choice (Ceftriaxone, Azithromycin, Vancomycin), Syrup Diphenhydramine and acetaminophen codeine for symptom control and amp Enoxaparin 40 mg SC daily during hospitalization. Intervention 2: Control group: this group doesnt receive extra drugs. Both groups receive tab hydroxychloroquine 200 mg BID for 5 days, Tab Acetaminophen Codeine and syrup diphenhydramine for symptom control, Antibiotics depend on physician choice (Ceftriaxone, Azithromycin, Vancomycin), Amp Enoxaparin 40 mg SC daily during hospitalization and amp Methylprednisolone 50 mg IV daily for 7 days. No - There is not a plan to make this available Justification or reason for not sharing IPD is no more informations
public Farzane Ashrafi
Ostanadari street
Isfahan Iran (Islamic Republic of) 1234567891 +98 31 3222 2127 farashrafi@yahoo.com Esfahan University of Medical Sciences scientific farzane ashrafi
Ostandari street
Isfahan Iran (Islamic Republic of) 1234567891 +98 31 3222 2127 farashrafi@yahoo.com Esfahan University of Medical Sciences Iran (Islamic Republic of) 18-75 year old men and 50-75 year old women admitted in hospital Spo2 less than 85% in admission Clinical symptoms and signs compatible with COVID19 infection and positive PCR test or lung HRCT abnormalities compatible with COVID19 pneumonia No need to intubation in first 24 hour of admission No multiorgan failure at presentation No shock state at presentation Obtained informed consent 18 years 75 years Both Hepatic failure (Child Pugh score ≥ C, AST> 5 times of the upper limit normal) Severe renal dysfunction (GFR less than 30cc per min) U07.1 disease diagnosis of COVID-19 confirmed by laboratory testing. Treatment - Drugs Treatment - Drugs Intervention group: Tab Thalidomide ( Talidex) from Alan pharmaceuticals, daily until 14 days. Both case and control group will be received hydroxychloroquine tablet 100 mg BD, methylprednisolon 50 mg IV, antibiotic depend on physician choice (Ceftriaxone, Azithromycin, Vancomycin), Syrup Diphenhydramine and acetaminophen codeine for symptom control and amp Enoxaparin 40 mg SC daily during hospitalization. Control group: this group doesnt receive extra drugs. Both groups receive tab hydroxychloroquine 200 mg BID for 5 days, Tab Acetaminophen Codeine and syrup diphenhydramine for symptom control, Antibiotics depend on physician choice (Ceftriaxone, Azithromycin, Vancomycin), Amp Enoxaparin 40 mg SC daily during hospitalization and amp Methylprednisolone 50 mg IV daily for 7 days Efficacy of Thalidomide in severe Covid19 pneumonia. Timepoint: Daily until discharge and then weekly until 28 days. Method of measurement: history, pulse oximetry, sphygmomanometer. 28 days survival rate. Timepoint: daily until discharge and then weekly until 28 days. Method of measurement: history. deputy minister of technology research Approved 2020-04-10 Ethics Committee of Isfahan University of Medical Sciences Isfahan University of Medical Sciences, Hezar Jerib street Isfahan Isfehan Iran (Islamic Republic of)