Phase 2
N=27
Enriched Heparin Anti COVID-19 Trial
Covid19
Bottom Line
View on ClinicalTrials.gov: NCT04743011 ↗Enrolled (actual)
27
Serious AEs
0.0%
Results posted
Oct 2024
Primary outcome: Primary: Change in Activated Partial Thromboplastin Time (APTT) > 1.5 Seconds — 0.95; 1.10 ratio
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Heparin sodium (Drug); Placebo (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- UPECLIN HC FM Botucatu Unesp
- Primary completion
- Nov 2021
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Activated Partial Thromboplastin Time (APTT) > 1.5 Seconds |
0.95; 1.10 | — |
| PRIMARY Number of Participants With a Negative Viral Load in Nasal Swab Reverse Transcription Polymerase Chain Reaction (RT-PCR). |
8; 8 | — |
| SECONDARY Number of Participants That Develop Renal Failure |
0; 0 | — |
| SECONDARY Number of Participants That Develop Major Cardiovascular Events |
0; 0 | — |
| SECONDARY Number of Participants That Develop Deep Vein Thrombosis (DVT) |
0; 0 | — |
| SECONDARY Number of Participants That Develop Pancreatitis |
0; 0 | — |
| SECONDARY Number of Deaths Among Participants |
0; 0 | — |
| SECONDARY Number of Participants With Increased C Reactive Protein Test |
2; 2 | — |
| SECONDARY Number of Participants With Deterioration of Arterial Blood Gas paO2/pFiO2 Ratio |
1; 1 | — |
| SECONDARY Number of Participants With Increased Pulmonary Area Compromised (%) |
1; 0 | — |
Summary
Coronavirus 19 (COVID-19) is a viral respiratory disease that was identified in December 2019 after the first cases in China, spreading rapidly until reaching pandemic status, causing the collapse of numerous health systems and strong economic and social impact. By the end of April 2020, 3.08 million cases, and more than 214 thousand deaths were already recorded. The treatment so far has not been established and there are several clinical trials testing known drugs that have antiviral activity in vitro, due to the urgency that the global situation imposes. Medicines with specific actions can take years to be discovered, while a vaccine also takes a long time. Recently, it has been shown that the worsening of Coronavirus infection may be related to the formation of micro clots in blood vessels and anticoagulants have been used as adjuvants in the treatment. This study is justified by conducting a pilot study that showed an in vitro antiviral action (anti-COVID-19) of high molecular weight heparin. Methods: A phase I / II clinical trial will be conducted. 40 participants will be included in two arms. Participants allocated to Group 1 (control) will receive inhalation with 0.9% saline applied 4/4 hours, for 7 days. Participants allocated to Group 2 (intervention) will receive high molecular weight inhaled heparin (250ug / mL 0.9% SF), at a 4/4 hour dose, for 7 days. The outcomes of interest will be safety (absence of moderate or serious adverse events) and effectiveness (measured in a score of 7 points, with 1 absence of limitations and 7, death). Expected results: The development of a new therapeutic option for COVID-19 is expected, with the possibility of use in other serious coronavirus diseases, to be subsequently tested in phase III studies.
Eligibility Criteria
Inclusion Criteria
- Signature and agreement to the Free Consent Form;
- Both sexes, of any ethnic origin, aged between 18 and 90 years;
- COVID-19 infected patients diagnosed by RT-PCR (reverse-transcriptase polymerase chain reaction) or with a strong suspicion of COVID-19 by clinical evaluation through compatible clinical and radiological findings;
- Time of disease evolution less than 10 days;
- Radiological diagnosis of grade 2A pneumonia, with gas exchange ratio > 200 on blood gas analysis (paO2 / pFiO2), characterizing mild hypoxemia;
- Indication of hospital treatment regime, provided that the period of hospitalization before inclusion is not more than 24 hours;
- Need for supplemental oxygen therapy (O2) less than 5L / min.
Exclusion Criteria
- No agreement to the terms of this study;
- Moderate or severe respiratory failure requiring admission to the ICU and the need for invasive mechanical ventilation or non-invasive ventilation (NIV) with positive pressure;
- Pregnancy or puerperium;
- Patients with hematological diseases, coagulation disorders, use of anticoagulants, previous heparin-induced allergy or thrombocytopenia, thrombocytopenia with a count of fewer than 50,000 platelets / mm3;
- COVID-19 not confirmed by RT-PCR within 72 hours of inclusion in the study.
Data sourced from ClinicalTrials.gov (NCT04743011). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.