Pembrolizumab (CinnaGen Co, Iran) in COVID-19
- Conditions
- COVID-19.COVID-19U07.1
- Registration Number
- IRCT20150303021315N19
- Lead Sponsor
- CinnaGen Company
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 62
Male or female patients aged 18 – 75 years while signing ICF
Able and willing to sign the informed consent
Patient with confirmed diagnosis of 2019-ncov infection based on RT-PCR and/or radiographic results
Clinical manifestation of:1- SpO2= 93% while resting and 2- Bilateral pulmonary involvement in radiographic results and 3- IL-6 < 7 pg/mL and 4- CRP < 50 mg/L and 5- Lymphocyte count > 800 cells/µL and 6- Ferritin < 300 µg/L
Adequate organ and marrow function
Critical patients defined as: 1- respiratory failure which requiring mechanical ventilation or 2- Shock or 3- combined with other organ failure, need to be admitted to ICU
Patients with hepatitis B or C, HIV or active tuberculosis
Patient with COPD or end-stage lung disease requires home oxygen therapy
Patients with interstitial lung disease (ILD)
The underlying disease is very serious and the expected survival time is less than 6 months (such as advanced malignant tumor)
Active hepatic disease and hepatic failure
Active or history of autoimmune disease
Patients with myocarditis
History of organ, bone marrow or hematopoietic Stem Cell transplantation
Received radiotherapy and chemotherapy for malignant tumor within 6 months
Has received or will receive a live vaccine within 30 days prior to the first administration of study medication. Seasonal flu vaccines that do not contain a live virus are permitted
Has received prior therapy with an anti-PD-1, anti-PD-L1, anti-PD-L2, anti-CD137, or anti-CTLA-4 antibody
Is receiving systemic steroid therapy < 3 days prior to the first dose of trial treatment or receiving any other form of immunosuppressive medication
Major surgery within 3 weeks before randomization
Hypersensivity to pembrolizumab, standard of care or any components of the formulation
90 days of retinal detachment or eye surgery
Permanent blindness in one eye, history of iritis, endophthalmitis, scleral inflammation or retinitis
Participated in other clinical intervention trials within the last 3 months
Pregnancy and breastfeeding
The competent physician considered it inappropriate to participate in the study
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Incidence of death during the study. Timepoint: at least 7 days. Method of measurement: Recording the incidence of death.
- Secondary Outcome Measures
Name Time Method