Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia

D'Or Institute for Research and Education

Status and phase: Withdrawn; Phase 3

Conditions: COVID-19

Treatments: Drug: Methylprednisolone; Drug: Heparin

Study type: Interventional

Funder types: Other

Identifiers

NCT04485429

31180820600005249

Details and patient eligibility

About

The COVID-19 pandemic has been spreading continuously, and in Brazil, until July 19, 2020, there have been more than 2,000,000 cases with more than 79,000 deaths, with daily increases. The present study proposes to evaluate the efficacy of methylprednisolone and heparin in treatment of patients with COVID-19 pneumonia in a randomized, controlled, 2x2 factorial study.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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 less than or equal to 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 hours after randomization)
• 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 hemodialysis
• History of peptic ulcer
• Herpes zoster infection
• History or active treatment of tuberculosis
• Systemic fungal infection
• Use of anticoagulation due to previous pathology
• Glaucoma
• Live virus vaccine up to 90 days before randomization
• Known coagulopathy or thrombocytopenia (<40,000/mm3) or hypofibrinogenemia (< 50 mg/dL)
• Recent bleeding
• Another limiting comorbidity for administering the therapies provided for in this protocol in in researcher's opinion

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Factorial Assignment

Masking: None (Open label)

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0 participants in 4 patient groups

Methylprednisolone + Standard treatment

Experimental group

Description:

Participants will receive the standard treatment and methylprednisolone.

Treatment:

Drug: Methylprednisolone

Full-dose heparin + Standard treatment

Experimental group

Description:

Participants will receive the standard treatment and full-dose heparin,

Treatment:

Drug: Heparin

Methylprednisolone + Full-dose heparin + Standard treatment

Experimental group

Description:

Participants will receive the standard treatment, methylprednisolone and full-dose heparin

Treatment:

Drug: Heparin

Drug: Methylprednisolone

Standard treatment

No Intervention group

Description:

Participants will receive the standard treatment