NCT04485429.

Study name	Efficacy assessment of methylprednisolone and heparin in patients with COVID‐19 pneumonia: a randomized, controlled, 2x2 factorial study
Starting date	20 July 2020
Contact information	Eduardo M Rego, MD, PhD D'Or Institute for Research and Education Rio de Janeiro, Brazil 55 16 981110090 | edumrego@hotmail.com
Methods	Open‐label, 2:2, parallel‐assignment RCT
Participants	268 participants, ≥ 18 years, female and male Inclusion criteria: Confirmed diagnosis of COVID‐19 by RT‐PCR or serology with presence of IgM‐positive antibodies Lung image (X‐ray or chest CT) with involvement of at least 25% of the parenchyma O2 saturation in ambient air ≤ 93% Alteration of inflammatory tests D‐Dimer above the reference value and elevation of C‐reactive protein, ferritin or lactic dehydrogenase Sign the consent form Exclusion criteria: QT interval prolongation Imminence of orotracheal intubation (intubation prediction in the first 4 h after randomisation) Women who are pregnant or breastfeeding Corticosteroid allergy or intolerance Chronic corticosteroid users (prednisone equivalent > 10 mg daily) Patients diagnosed with cancer with increased bleeding potential Patients in haemodialysis History of peptic ulcer Herpes zoster infection History or active treatment of TB Systemic fungal infection Use of anticoagulation due to previous pathology Glaucoma Live virus vaccine up to 90 days before randomisation Known coagulopathy or thrombocytopenia (< 40,000/mm³) or hypofibrinogenaemia (< 50 mg/dL) Recent bleeding Another limiting comorbidity for administering the therapies provided for in this protocol in researcher's opinion
Interventions	Experimental: Methylprednisolone + standard treatment Participants will receive the standard treatment and methylprednisolone Full‐dose heparin + standard treatment Participants will receive the standard treatment and full‐dose heparin Methylprednisolone + full‐dose heparin + standard treatment Participants will receive the standard treatment, methylprednisolone and full‐dose heparin Comparator: standard treatment Participants will receive the standard treatment
Outcomes	Primary Rate of invasive mechanical ventilation (time frame: 28 days) Secondary Severity assessment by ordinal severity scale (time frame: 3 days, 7 days, 14 days, 28 days after randomisation) Severity assessment by SOFA score (time frame: 3 days, 7 days, 14 days, 28 days after randomisation) Length of hospital stay (time frame: 28 days) Length of stay in ICU (time frame: 28 days) Death rate (time frame: 14 days, 28 days, 60 days, 90 days after randomisation)
Notes	NCT04485429 | No data provided