COVID-19 trials registries data warehouse

http://en.irct.ir/trial/60236

Hatam Godini P.H.D

h.godini@abzums.ac.ir

2021-12-06

Completed

RCT

Randomized

Parallel

Blind label

single-center

Treatment

Age 80-18 years Patients with a definitive diagnosis of Covid-19 based on PCR test within 48 hours after hospitalization Acute moderate respiratory distress syndrome with PaO2 / FiO2 <200 based on Berlin criteria (Force et al., 2012) Patients with severe dyspnea Patients in the end-stages of the disease Lack of proper treatment Patients with consent to participate in the project

Patients with high suspicion / diagnosis of heart failure and unstable angina Existence of severe shock with hemodynamic instability despite increased vascular pressure Severe / undiagnosed lung infection for other reasons (chronic obstructive pulmonary disease, pulmonary fibrosis, lung cancer, bacterial pneumonia ...) Diagnosis of pulmonary hemorrhage Pregnancy / breastfeeding An important cause other than acute respiratory distress for respiratory failure Requires ECMO during the study period He/she is expected to be transferred to another hospital within 72 hours Known allergies to morphine Sensitivity or contraindication to exogenous and endogenous opioids Obesity (BMI>35 kg/m2 ) Patients with dissatisfaction with participating in the project

2

Karaj University of Medical Sciences

18

80

Iran

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

60

Mortality rate

Phase 2/Phase 3

[{"arm_notes": "through nebulizer mask", "treatment_id": 818, "treatment_name": "Morphine", "treatment_type": "Central nervous system agents", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]