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IRCT20150303021315N19 IRCT 2020-05-27 CinnaGen Company Pembrolizumab (CinnaGen Co, Iran) in COVID-19 The evaluation of safety and efficacy of Pembrolizumab (CinnaGen Co, Iran) in patients with COVID-19 2020-06-06 anticipated 62 Complete https://irct.ir/trial/47335 interventional Randomization: N/A, Blinding: Not blinded, Placebo: Not used, Assignment: Single, Purpose: Treatment. 2 COVID-19. 200 mg intravenous pembrolizumab (produced by CinnaGen company) single dose on day 1, in combination with standard of care during treatment. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is It is not yet known if there will be a plan to make this available
public Nasim Anjidani
No. 42, Atar St, Attar Sq
Tehran Iran (Islamic Republic of) 1468813112 +98 21 4347 3000 anjidani.n@orchipharmed.com Orchid Phramed Co. scientific Payam Tabarsi
Darabad, Shahid Bahonar Ave, Massih Daneshvari Hospital
Tehran Iran (Islamic Republic of) 1956944413 +98 21 2610 5050 payamtabarsi@yahoo.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) 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 18 years 70 years Both 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 U07.1 COVID-19 Treatment - Drugs 200 mg intravenous pembrolizumab (produced by CinnaGen company) single dose on day 1, in combination with standard of care during treatment Incidence of death during the study. Timepoint: at least 7 days. Method of measurement: Recording the incidence of death. Days of hospitalization. Timepoint: Daily. Method of measurement: Counting the days of hospitalization. Changing patient’s condition to critical (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). Timepoint: Daily. Method of measurement: Examination and diagnosis by competent physician. Percentage of patients with negative RT-PCR for nCoV-2019. Timepoint: Screening day, day 7 or discharge day. Method of measurement: Diagnostic kit. Changes in percentage of SpO2 during study. Timepoint: Several times in a day. Method of measurement: Oxygen saturation test. The lesions of the pulmonary segment numbers involved in pulmonary graphy. Timepoint: Screening day, day 7 or discharge day. Method of measurement: CT-scan or chest x-ray. Changes in lymphocyte count. Timepoint: Daily. Method of measurement: Laboratory Test. Changes in neutrophil count. Timepoint: Daily. Method of measurement: Laboratory Test. Changes in CRP level. Timepoint: Daily. Method of measurement: Laboratory Test. Peripheral edema. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. Cardiac arrhythmia. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. Fatigue. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. Pain. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. Headache. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. Pruritus. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. Skin rash. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. Vitiligo. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. Hyperglycemia. Timepoint: Daily. Method of measurement: Laboratory test. Hyperalbuminemia. Timepoint: every other day. Method of measurement: Laboratory test. Hypocalcemia. Timepoint: every other day. Method of measurement: Laboratory test. Hyponatremia. Timepoint: every other day. Method of measurement: Laboratory test. Hypophosphatemia. Timepoint: every other day. Method of measurement: Laboratory test. Hypocalcemia. Timepoint: every other day. Method of measurement: Laboratory test. Hypokalemia. Timepoint: every other day. Method of measurement: Laboratory test. Hypogycemia. Timepoint: Daily. Method of measurement: Laboratory test. Hypercalcemia. Timepoint: every other day. Method of measurement: Laboratory test. Hyperkalemia. Timepoint: every other day. Method of measurement: Laboratory test. Hypothyroidism. Timepoint: Screening day, day 7 or discharge day. Method of measurement: Laboratory test. Diarrhea. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. Decreased appetite. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. Constipation. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. Abdominal pain. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. Nausea. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. Vomiting. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. Urinary tract infection. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. Hematuria. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. Anemia. Timepoint: Daily. Method of measurement: Laboratory test. Leukopenia. Timepoint: Daily. Method of measurement: Laboratory test. Thrombocytopenia. Timepoint: Daily. Method of measurement: Laboratory test. Hemorrhage. Timepoint: In each visit by physician. Method of measurement: Clinical evaluation. Increased INR. Timepoint: every other day. Method of measurement: Laboratory test. Prolonged partial thromboplastin time. Timepoint: every other day. Method of measurement: Laboratory test. Increased serum alkaline phosphatase. Timepoint: every other day. Method of measurement: Laboratory test. Increased serum alanine aminotransferase. Timepoint: every other day. Method of measurement: Laboratory test. Increased serum aspartate aminotransferase. Timepoint: every other day. Method of measurement: Laboratory test. Infection. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. Masculoskeletal pain. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. Back pain. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. Asthenia. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. Increased serum creatinine. Timepoint: every other day. Method of measurement: Laboratory test. Upper respiratory tract infection. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. Cough. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. Dyspnea. Timepoint: In each visit by physician. Method of measurement: Clinical Evaluation. CinnaGen Company Approved 2020-05-21 National Research Institute of Tuberculosis and Lung Diseases Masih Daneshvari Masih Daneshvari Hospital, Darabad Avenue, Shahid Bahonar roundabout, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)