Randomized Proof-of-Concept Trial to Evaluate the Safety and Explore the Effectiveness of Resveratrol, a Plant Polyphenol, for COVID-19

NCT ID: NCT04400890

Last Updated: 2023-02-24

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 105 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-09-13
• Study Completion Date: 2021-03-01

Brief Summary

Resveratrol is a plant polyphenol (that is sold commercially as a supplement) that might help fight coronavirus as well as help protect the body from the effects of disease (COVID-19) caused by the infection. In this proof-of-concept pilot study we will compare the effects of resveratrol to placebo to assess the safety of the resveratrol and explore effectiveness.

Detailed Description

This randomized placebo-controlled trial is for the outpatient treatment of (Coronavirus Disease 2019) COVID-19. The purpose of this trial is to evaluate the safety and explore the effectiveness of resveratrol, a plant polyphenol, being re-purposed for patients with early COVID-19. Published in vitro data supports that this polyphenol inhibits coronavirus replication while separately published in silico (computer molecular docking analysis) reports have identified specific molecular targets of resveratrol against (Severe Acute Respiratory Syndrome - Coronavirus 2) SARS-CoV-2. Animal studies also demonstrate that resveratrol is effective at preventing lung injury and death in certain animal models of viral infections. Furthermore, the products long history as an anti-inflammatory might prevent the cytokine storm that is associated with worse outcomes in COVID-19.

200 subjects, 45 and older, (100 receiving the plant polyphenol, 100 receiving placebo) will be enrolled in study to compare whether taking resveratrol will reduce the rate of hospitalization. Subjects will take capsules 4 times a day for a minimum of 7 days (up to 15 days depending on duration of symptoms) plus both groups will receive Vitamin D3 100,000 IU to augment the effects of resveratrol. Resveratrol will be given as 1gm 4 times per day. Placebo tablets will contain brown rice flour in visually identical capsules. The primary outcome measure for this trial is reduction in hospitalization at 21 days from enrollment.

Conditions

COVID-19

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

Resveratrol with Vitamin D3

Resveratrol 1000mg four times per day for 15 days. Vitamin D3 100,000 IU on day 1

Group Type: ACTIVE_COMPARATOR

Resveratrol

Intervention Type: DRUG

Resveratrol vs placebo given for 15 days.

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3 100,000 IU given on day one.

Placebo with Vitamin D3

Placebo capsules 4 times per day for 15 days. Vitamin D3 100,000 IU on day 1

Group Type: PLACEBO_COMPARATOR

Vitamin D3

Intervention Type: DIETARY_SUPPLEMENT

Vitamin D3 100,000 IU given on day one.

Interventions

Resveratrol

Resveratrol vs placebo given for 15 days.

Intervention Type: DRUG

Vitamin D3

Vitamin D3 100,000 IU given on day one.

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

Placebo

Eligibility Criteria

Inclusion Criteria

• Outpatients who test positive for infection with SARS-CoV-2.
• Age ≥45 years
• Mild COVID-19 based on World Health Organization (WHO) Baseline Severity Categorization
• Symptom duration ≤ 10 days, or <72 hours of new respiratory symptoms.
• Patient must have access to the internet or a smartphone to complete surveys.
• English-speaking patients

Exclusion Criteria

• Diagnosed or suspected cognitive impairment that would prevent the patient from cooperating with study procedures, as judged by the screening clinician
• Asymptomatic patients (e.g. patients who were screened without symptoms but tested positive)
• Known or suspected liver disease or Hepatitis C
• Known kidney disease with estimate Glomerular Filtration Rate (eGFR) <60
• Patients on warfarin, Novel Oral Anticoagulants (NOACs), HIV Protease Inhibitors, immunosuppressants, hydroxychloroquine/chloroquine, and other medication with a narrow therapeutic window.
• Allergy to grapes or rice.
• Co-morbidities with a high likelihood of hospitalization within 30 days (e.g., current cancer treatment, severe Chronic Obstructive Pulmonary Disease (COPD) or Congestive Heart Failure (CHF))
• Currently pregnant
• Hospitalization

• Minimum Eligible Age: 45 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Marvin McCreary, MD

OTHER

Sponsor Role: lead

Responsible Party

Marvin McCreary, MD

Emergency Physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Marvin R McCreary

Role: PRINCIPAL_INVESTIGATOR

Mount Carmel Health System

Locations

Mt Carmel HealthSystems

Columbus, Ohio, United States

Countries

United States

References

McCreary MR, Schnell PM, Rhoda DA. Randomized double-blind placebo-controlled proof-of-concept trial of resveratrol for outpatient treatment of mild coronavirus disease (COVID-19). Sci Rep. 2022 Jun 29;12(1):10978. doi: 10.1038/s41598-022-13920-9.

Reference Type: DERIVED

PMID: 35768453 (View on PubMed)

McCreary MR, Schnell PM, Rhoda DA. Randomized Double-blind Placebo-controlled Proof-of-concept Trial of Resveratrol for Outpatient Treatment of Mild Coronavirus Disease (COVID-19). Res Sq [Preprint]. 2021 Sep 13:rs.3.rs-861831. doi: 10.21203/rs.3.rs-861831/v1.

Reference Type: DERIVED

PMID: 34545357 (View on PubMed)

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: Study Protocol with SAP

View Document

Related Links

https://www.nature.com/articles/s41598-022-13920-9

Peer reviewed final publication

Other Identifiers

McCreary2020

Identifier Type: -

Identifier Source: org_study_id