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It was not possible to perform the study due to the availability and logistics of porcine heparin
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Methylprednisolone + Standard treatment | Experimental | Participants will receive the standard treatment and methylprednisolone. |
|
| Full-dose heparin + Standard treatment | Experimental | Participants will receive the standard treatment and full-dose heparin, |
|
| Methylprednisolone + Full-dose heparin + Standard treatment | Experimental | Participants will receive the standard treatment, methylprednisolone and full-dose heparin |
|
| Standard treatment | No Intervention | Participants will receive the standard treatment |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Methylprednisolone | Drug | Methylprednisolone 0.5 mg/kg every 12 hours intravenously for the first 14 days; followed by 0.5 mg/kg/day from day 15 to day 21; followed by 0.25mg/kg/day from day 22 to day 25; followed by 0.125 mg/kg/day, from day 26 to day 28 of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Rate of invasive mechanical ventilation | 28 days |
| Measure | Description | Time Frame |
|---|---|---|
| Severity assessment by ordinal severity scale | Severity assessment will be performed using the ordinal severity scale during hospitalization. | 3 days, 7 days, 14 days, 28 days after randomization |
| Severity assessment by SOFA score |
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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
Sign the consent form.
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Eduardo M Rego, MD, PhD | D'Or Institute for Research and Education | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| D'Or Institute for Research and Education | Rio de Janeiro | Brazil |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35244208 | Derived | 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: a rapid review. Cochrane Database Syst Rev. 2022 Mar 4;3(3):CD013739. doi: 10.1002/14651858.CD013739.pub2. |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D020141 | Hemostatic Disorders |
| D012131 | Respiratory Insufficiency |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| D006493 | Heparin |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
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| Heparin | Drug | Enoxaparin 1 mg/kg subcutaneously every 12 hours (if creatinine clearance greater than 40ml/min) or Unfractionated heparin dosed to target activated partial thromboplastin time (aPTT) between 1.5 - 2.0 times the normal value (if creatinine clearance less or equal to 40ml/min). The treatment period with full-dose heparin will be 7 days. After 7 days of full-dose heparin, patients will continue using prophylactic dose of heparin, according to the standard treatment routine. |
|
Severity assessment will be performed using the SOFA score during hospitalization.
| 3 days, 7 days, 14 days, 28 days after randomization |
| Length of hospital stay | 28 days |
| Length of stay in intensive care | 28 days |
| Death rate | 14 days, 28 days, 60 days, 90 days after randomization |
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D006474 | Hemorrhagic Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D012120 | Respiration Disorders |
| D013256 |
| Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D006025 | Glycosaminoglycans |
| D011134 | Polysaccharides |
| D002241 | Carbohydrates |