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.
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.
Drug: Resveratrol
Resveratrol vs placebo given for 15 days.
Other Name: Placebo
Dietary Supplement: Vitamin D3
Vitamin D3 100,000 IU given on day one.
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
Mt Carmel HealthSystems
Columbus, Ohio, United States
Marvin R McCreary, Principal Investigator
Mount Carmel Health System