COVID-19 trials registries data warehouse

http://en.irct.ir/trial/47641

Gholamhosein Alishiri

R.bmsu@yahoo.com

2020-05-05

Completed

RCT

Randomized

Parallel

Open label

single-center

Treatment

Confirmed diagnosis of COVID-19, with either lung CT-Scan result, which is typical for COVID-19 pulmonary involvement,or RT-PCR confirmation. The patient has written consciously and freely consent to participate in the study; The patient has moderate to severe Corona-Virus associated pneumonia; In the first 48 hours of hospitalization, the patient did not show an improving trend; In the first 48 hours after his/her inclusion into this study, there is no possibility of discharge from the patient's hospital;

History of hypersensitivity reaction to glucocorticoids; Recent hospitalization and treatment history due to COVID-19; Receive antiviral drugs before including into this study, such as: Hydroxychloroquine, Kaletra, Ribavirin, Oseltamivir; Receiving Methylprednisolone pulse before including into this study; Uncontrolled severe chronic illnesses, including heart failure, kidney failure, liver failure, active cancer (history of chemotherapy within recent month), diabetes; Receiving immunosuppressing /immunomodulating agents, such as systemic glucocorticoids. Pregnancy; Lactation.

2

Bagheiat-allah University of Medical Sciences

18

85

Iran

Moderate/severe disease at enrollment

4: Moderate/severe disease at enrollment

50

Need to receive ICU service (occurrence of shock, resistant hypoxemia despite receiving oxygen via reservoir oxygen mask, GCS score drops below 12)

Phase 3

[{"arm_notes": "Methylprednisolone followed by prednisolone ", "treatment_id": 1634, "treatment_name": "Methylprednisolone+prednisolone", "treatment_type": "Corticosteroids", "pharmacological_treatment": "Pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2188, "treatment_name": "Standard of care", "treatment_type": "Standard of care", "pharmacological_treatment": "Standard of care"}]