Clinical trial NCT04485429: Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia
Official title: Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia: A Randomized, Controlled, 2x2 Factorial Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: COVID-19
Keywords: SARS-CoV-2
Heparin
Methylprednisolone
Anticoagulation
Coagulopathy
Respiratory failure
Lead sponsor: D'Or Institute for Research and Education
Sponsor class: OTHER
First posted: 2020-07-24
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: 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

Primary outcomes:
measure: Rate of invasive mechanical ventilation
timeFrame: 28 days
Secondary outcomes:
measure: Severity assessment by ordinal severity scale
timeFrame: 3 days, 7 days, 14 days, 28 days after randomization
measure: Severity assessment by SOFA score
timeFrame: 3 days, 7 days, 14 days, 28 days after randomization
measure: Length of hospital stay
timeFrame: 28 days
measure: Length of stay in intensive care
timeFrame: 28 days
measure: Death rate
timeFrame: 14 days, 28 days, 60 days, 90 days after randomization
Other outcomes:
Locations:
city: Rio de Janeiro
country: Brazil
facility: D'Or Institute for Research and Education
Study officials:
affiliation: D'Or Institute for Research and Education
name: Eduardo M Rego, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Flumignan RL, Civile VT, Tinoco JDS, Pascoal PI, Areias LL, Matar CF, Tendal B, Trevisani VF, Atallah AN, Nakano LC. Anticoagulants for people hospitalised with COVID-19. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2.