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

NCT04400890 | Terminated Phase 2 Results DMC FDA Drug

• 1 other identifier: McCreary2020
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

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.

Conditions

COVID-19

Keywords

Coronavirus; SARS-CoV-2; COVID; Vitamin D3; Cholecalciferol; Supplement; Polyphenol; Resveratrol; Stilbene; phytoalexin

Outcome Measures

Primary Outcomes (1)

• Hospitalization Rates for COVID-19

  Number of study participants admitted to the hospital within 21 days of randomization

  21 days from study randomization

Secondary Outcomes (5)

• ICU Admission Rates

  21 days from randomization

• Invasive Ventilation Rates

  21 days from randomization

• Pneumonia

  21 days from randomization

• Pulmonary Embolism

  21 days from start of randomization.

• Death

  Within 21 days from randomization

Other Outcomes (1)

• Adverse Events

  60 days from randomization

Study Arms (2)

Resveratrol with Vitamin D3

ACTIVE COMPARATOR

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

Drug: Resveratrol; Dietary Supplement: Vitamin D3

Placebo with Vitamin D3

PLACEBO COMPARATOR

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

Dietary Supplement: Vitamin D3

Interventions

Resveratrol DRUG

Resveratrol vs placebo given for 15 days.

Also known as: Placebo

Resveratrol with Vitamin D3

Vitamin D3 DIETARY_SUPPLEMENT

Vitamin D3 100,000 IU given on day one.

Placebo with Vitamin D3; Resveratrol with Vitamin D3

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Marvin McCreary, MD: lead

Study Sites (1)

Mt Carmel HealthSystems

Columbus, Ohio, 43213, United States

Location

Related Publications (2)

• 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.

  PMID: 35768453 DERIVED

• 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.

  PMID: 34545357 DERIVED

Related Links

• Peer reviewed final publication

MeSH Terms

Conditions

COVID-19; Coronavirus Infections

Interventions

Resveratrol; Cholecalciferol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Stilbestrols; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polyphenols; Phenols; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Limitations and Caveats

The actual rate of primary and secondary COVID-19 outcome measures were lower than expected. Therefore the study plan had inadequate number of participants and was therefore under-powered.

Results Point of Contact

• Title: Marvin McCreary, MD
• Organization: formerly of Mount Carmel Health Systems

Marvin.McCreary+RCT@gmail.com

614-526-8492

Study Officials

• Marvin R McCreary

  Mount Carmel Health System

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Emergency Physician

Study Record Dates

• First Submitted: May 22, 2020
• First Posted: May 26, 2020
• Study Start: September 13, 2020
• Primary Completion: March 1, 2021
• Study Completion: March 1, 2021
• Last Updated: February 24, 2023
• Results First Posted: February 24, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

US (1)