Thalidomide in COVID19

• Register: IRCT
• Last refreshed on: 18 May 2020
• Main ID: IRCT20170207032444N3
• Date of registration: 2020-04-17
• Prospective Registration: No
• Primary sponsor: Esfahan University of Medical Sciences
• Public title: Thalidomide in COVID19
• Scientific title: The efficacy and safety of Thalidomide in severe Covid19 pneumonia: Arandomized controlled clinical trial
• Date of first enrolment: 2020-04-15
• Target sample size: 60
• Recruitment status: Recruiting
• URL: http://en.irct.ir/trial/47119
• Study type: interventional
• Study design: 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.
• Phase: 3

Countries of recruitment

Iran (Islamic Republic of)

Contacts

• Name: Farzane Ashrafi
• Affiliation: Esfahan University of Medical Sciences

• Name: farzane ashrafi
• Affiliation: Esfahan University of Medical Sciences

Key inclusion & exclusion criteria

Inclusion criteria: 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
Exclusion criteria: Hepatic failure (Child Pugh score = C, AST> 5 times of the upper limit normal)
Severe renal dysfunction (GFR less than 30cc per min)

Age minimum: 18 years
Age maximum: 75 years
Gender: Both

Health Condition(s) or Problem(s) studied

COVID19.
disease diagnosis of COVID-19 confirmed by laboratory testing.

U07.1

Intervention(s)

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.

Primary Outcome(s)

Efficacy of Thalidomide in severe Covid19 pneumonia. Timepoint: Daily until discharge and then weekly until 28 days. Method of measurement: history, pulse oximetry, sphygmomanometer.

Secondary Outcome(s)

28 days survival rate. Timepoint: daily until discharge and then weekly until 28 days. Method of measurement: history.

Source(s) of Monetary Support

deputy minister of technology research

Ethics review

Status: Approved
Approval date: 10/04/2020
Contact:

Ethics Committee of Isfahan University of Medical Sciences