COVID-19Phase 3NCT04485429
Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia
A Phase 3 study testing Methylprednisolone and Heparin in people with COVID-19, run by D'Or Institute for Research and Education at 1 site in Brazil.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Methylprednisolone and Heparin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteBrazil
- Study dates
- 20 Jul 2020to 31 Dec 2022
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
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- 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 locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia: A Randomized, Controlled, 2x2 Factorial Study
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.
- Conditions
- COVID-19
- Being tested
- Methylprednisolone, Heparin
- Keywords
- SARS-CoV-2, Heparin, Methylprednisolone, Anticoagulation, Coagulopathy, Respiratory failure
- Medical subject headings
- COVID-19, Hemostatic Disorders, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
HeparinDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Methylprednisolone + Standard treatment | Experimental | Participants will receive the standard treatment and methylprednisolone. Receives: Drug: Methylprednisolone |
| Full-dose heparin + Standard treatment | Experimental | Participants will receive the standard treatment and full-dose heparin, Receives: Drug: Heparin |
| Methylprednisolone + Full-dose heparin + Standard treatment | Experimental | Participants will receive the standard treatment, methylprednisolone and full-dose heparin Receives: Drug: Methylprednisolone; Drug: Heparin |
| Standard treatment | No intervention | Participants will receive the standard treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of invasive mechanical ventilation
Measured: 28 days
Secondary outcomes (5)
Severity assessment by ordinal severity scale
Severity assessment will be performed using the ordinal severity scale during hospitalization.
Measured: 3 days, 7 days, 14 days, 28 days after randomization
Severity assessment by SOFA score
Severity assessment will be performed using the SOFA score during hospitalization.
Measured: 3 days, 7 days, 14 days, 28 days after randomization
Length of hospital stay
Measured: 28 days
Length of stay in intensive care
Measured: 28 days
Death rate
Measured: 14 days, 28 days, 60 days, 90 days after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2020
- Study start20 Jul 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Dec 2022 (estimated)
Why it stopped: It was not possible to perform the study due to the availability and logistics of porcine heparin
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- D'Or Institute for Research and Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Eduardo M Rego, MD, PhD, Principal investigator, D'Or Institute for Research and Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04485429
- Sponsor's protocol ID
- 31180820600005249
- Status last verified
- Aug 2021
- First submitted
- 20 Jul 2020
- Last updated
- 11 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35244208
Study at a glance
From the registry record, last updated by the sponsor on 11 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy Assessment of Methylprednisolone and Heparin in Patients With COVID-19 Pneumonia: A Randomized, Controlled, 2x2 Factorial Study
- ClinicalTrials.gov ID
- NCT04485429
- Acronym / sponsor ID
- 31180820600005249
- Conditions
- COVID-19
- Keywords
- SARS-CoV-2, Heparin, Methylprednisolone, Anticoagulation, Coagulopathy, Respiratory failure
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: It was not possible to perform the study due to the availability and logistics of porcine heparin
- Enrolment
- 0 participants (actual)
- Lead sponsor
- D'Or Institute for Research and EducationUniversity, hospital or other
- Study start
- 20 Jul 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Dec 2022 (estimated)
- First posted
- 24 Jul 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Methylprednisolone + Standard treatment | Experimental | Drug: MethylprednisoloneParticipants will receive the standard treatment and methylprednisolone. |
| Full-dose heparin + Standard treatment | Experimental | Drug: HeparinParticipants will receive the standard treatment and full-dose heparin, |
| Methylprednisolone + Full-dose heparin + Standard treatment | Experimental | Drug: Methylprednisolone, Drug: HeparinParticipants will receive the standard treatment, methylprednisolone and full-dose heparin |
| Standard treatment | No intervention | –Participants will receive the standard treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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.
Key exclusion criteria (17 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MethylprednisoloneMethylprednisolone 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. | Drug | Methylprednisolone + Full-dose heparin + Standard treatment, Methylprednisolone + Standard treatment |
| HeparinEnoxaparin 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. | Drug | Full-dose heparin + Standard treatment, Methylprednisolone + Full-dose heparin + Standard treatment |
Primary outcome
Rate of invasive mechanical ventilation
Time frame: 28 days
5 secondary outcomes
Severity assessment by ordinal severity scale
Time frame: 3 days, 7 days, 14 days, 28 days after randomization
Severity assessment by SOFA score
Time frame: 3 days, 7 days, 14 days, 28 days after randomization
Length of hospital stay
Time frame: 28 days
Length of stay in intensive care
Time frame: 28 days
Death rate
Time frame: 14 days, 28 days, 60 days, 90 days after randomization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2021.
- Derived from this study: PubMed 35244208Flumignan 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eduardo M Rego, MD, PhD principal investigator
D'Or Institute for Research and Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Methylprednisolone and Heparin in people with COVID-19, run by D'Or Institute for Research and Education at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 11 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of invasive mechanical ventilation (time frame: 28 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04485429, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Aug 2021.