COVID-19. COVID-19
Conditions
Interventions
200 mg intravenous pembrolizumab (produced by CinnaGen company) single dose on day 1, in combination with standard of care during treatment.
Sponsors
CinnaGen Company
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 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-6 800 cells/µL and 6- Ferritin < 300 µg/L Adequate organ and marrow function
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of death during the study. Timepoint: at least 7 days. Method of measurement: Recording the incidence of death. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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 mea | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactNasim Anjidani
Orchid Phramed Co.
Outcome results
None listed