Trial of Open Label Dipyridamole- In Hospitalized Patients With COVID-19

NCT04424901 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: 20-192-2.F
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

Brief Summary: The goal here is to evaluate dipyridamole in treating respiratory tract infection and circulatory dysfunction due to SARS-CoV-2 coronavirus in hospitalized CVID-19 patients. Infection with SARS-CoV-2 causes human COVID-19 (HCoV-19). The infection is associated with a deleterious inflammatory response and a prothrombotic state in addition to tissue damage from direct viral entry and proliferation. Dipyridamole has anti-platelet and anti-inflammatory effects. The drug was recently demonstrated to have anti-SARS-Cov-2 effect primarily in vitro. The concentration causing anti-viral effect in vitro is within that in the blood of humans taking this drug. As an oral tablet, it has the advantage of easy administration. Anti thrombotic, anti viral and anti inflammatory actions of this drug may be efficacious and safe in hospitalized subjects

Conditions

COVID-19 Pneumonia; Vascular Complications

Outcome Measures

Primary Outcomes (2)

• D-dimer

  Percent Change from Baseline \[Day Zero\] to last study measure (Day 3, Day 6 or Day 9)

  up to 9 days

• Platelet Count

  Percent Change from Baseline \[Day Zero\] to last study measure (Day 3, Day 6 or Day 9)

  up to 9 days

Secondary Outcomes (1)

• Viral Detection

  9 days

Other Outcomes (6)

• Survival

  9 days

• Inflammatory Markers

  9 days

• Blood Markers

  9 days

Study Arms (2)

Standard Care

PLACEBO COMPARATOR

Hospitalized patients meeting screen criteria receive standard Hospital care from which clinical event and lab data are collected. Day 3,6 \& 9 research samples will be used for obtaining immunological profiles as well as metabolomic profiling and whole genome sequencing for discovery of new biomarkers/ genomic regions that confer increased susceptibility to infection and DIP treatment efficacy or safety. Other samples will be obtained for microbiome and viral analyses. Data collection ends on day 9.

Drug: Placebo

Standard Care with Dipyridamole

EXPERIMENTAL

For this arm, Dipyridamole 100 mg, tid is given for 7 days. Hospitalized patients meeting screen criteria receive standard Hospital care from which clinical event and lab data are collected. Day 3,6 \& 9 research samples will be used for obtaining immunological profiles as well as metabolomic profiling and whole genome sequencing for discovery of new biomarkers/ genomic regions that confer increased susceptibility to infection and DIP treatment efficacy or safety. Other samples will be obtained for microbiome and viral analyses. Data collection ends on day 9.

Drug: Dipyridamole Tablets

Interventions

Placebo DRUG

Daily dose while hospitalized up to 9 days

Standard Care

Dipyridamole Tablets DRUG

Daily dose while hospitalized up to 9 days

Also known as: Persantine

Standard Care with Dipyridamole

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years of age.
• COVID-19 positive by PCR and hospitalized for respiratory infection with a range of respiratory severity as follows.
• Moderate ● Diagnosed with SARS-CoV-2 infection by standard RT-PCR assay or equivalent testing
• ● Symptoms of moderate illness with COVID-19, which could include:
• o Fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms; shortness of breath with exertion
• Clinical signs suggestive of moderate illness with COVID-19, such as:
• o RR ≥ 20, HR ≥ 90, SaO2 ≥93% on room air or requires ≤2L oxygen by nasal cannula (NC) in order maintain SaO2 ≥93%, fever \>38.3 Celsius
• No clinical signs indicative of Severe or Critical Illness Severity
• Severe
• Diagnosed with SARS-CoV-2 infection by standard RT-PCR assay or equivalent testing
• Symptoms suggestive of severe systemic illness with COVID-19, which could include:
• o any symptom of Moderate Illness; shortness of breath at rest or respiratory distress
• Clinical signs indicative of severe systemic illness with COVID-19, such as
• o RR ≥ 30, HR ≥ 125, requires \> 2L oxygen by NC in order maintain SaO2 ≥93%, PaO2/FiO2 \<300
• No criteria for Critical Severity

You may not qualify if:

• Inability to swallow or ingest oral medication in either tablet form or in suspension form.
• Patient is known to be pregnant
• Patients with a history of allergy or hypersensitivity to dipyridamole
• Patient is unable to consent -intubated, on mechanical ventilation
• Bleeding disorders (e.g. thrombocytopenia with platelet counts \< 50,000)
• Existing severe medical illnesses unrelated to Covid-19 infection such as end stage heart, kidney, liver disorders;
• or hepatic insufficiency defined as liver enzymes ≥5 times upper limit normal if baseline is normal or 5 times baseline if baseline is abnormal.
• Metastatic cancer as well as those with severe coronary artery disease, unstable angina, STEMI, NSTEMI, hypotension (systolic blood pressure \<90mmHg), myocarditis, bradycardia with resting heart rate less than 60 bpm, atrioventricular block without pacemaker.
• Those with myasthenia gravis and those treated with cholinesterase inhibitors
• Patient is enrolled in a clinical trial for another investigational drug designed to test for efficacy for SARS-CoV-2

Sponsors & Collaborators

• UConn Health: lead

Study Sites (1)

UConn Health

Farmington, Connecticut, 06030, United States

Location

MeSH Terms

Interventions

Dipyridamole

Intervention Hierarchy (Ancestors)

Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Limitations and Caveats

No data obtained beyond 9 days of enrollment. If discharged from care, phone follow up limited to data provided by subject report, up to day 9.

Results Point of Contact

• Title: Ellen Ciesielski
• Organization: UConnHealth

eciesielski@uchc.edu

860-679-6004

Study Officials

• Bruce Liang, MD

  UConn Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Medicine School of Medicine

Model Details: Randomized Open Label Study Standard Care vs. Standard Care with Dipyridamole

Study Record Dates

• First Submitted: May 29, 2020
• First Posted: June 11, 2020
• Study Start: May 3, 2020
• Primary Completion: March 22, 2022
• Study Completion: April 24, 2022
• Last Updated: April 21, 2023
• Results First Posted: April 21, 2023

Record last verified: 2023-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)