NCT04424901

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

A Randomized, Open-label Study of the Vascular and Microbiologic Efficacy of Dipyridamole Plus Standard Care vs. Standard Care in Hospitalized COVID19 Patients

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: UConn Health · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Detailed description

The original protocol stipulated an enrollment of 100 patients, randomized in a 1 to 1 distribution of treatment versus control \[placebo\] group. However, the study was terminated because of insufficient enrollment due to the dramatic reduction in the number of hospitalized COVID patients. A total of 41 patients were randomized prior to study termination. Detailed reports and overall results were reviewed for all patients. Adverse event occurrences were similar in groups. Given the severity of COVID, these numbers were not unexpected. The DSMC concluded that all the AEs seen in study subjects are either unrelated or probably unrelated to the TOLD study intervention. The DSMC reviewed the primary outcome results. No statistically significant change in either the platelet count or the D-dimer results.

Conditions

• COVID-19 Pneumonia
• Vascular Complications

Interventions

Type	Name	Description
DRUG	Placebo	Daily dose while hospitalized up to 9 days
DRUG	Dipyridamole Tablets	Daily dose while hospitalized up to 9 days

Timeline

• Start date: 2020-05-03
• Primary completion: 2022-03-22
• Completion: 2022-04-24
• First posted: 2020-06-11
• Last updated: 2023-04-21
• Results posted: 2023-04-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study