Randomized Proof-of-Concept Trial to Evaluate the Safety and Explore the Effectiveness of Resveratrol, a Plant Polyphenol, for COVID-19
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| ClinicalTrials.gov Identifier: NCT04400890 |
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Recruitment Status :
Terminated
(Feasibility)
First Posted : May 26, 2020
Last Update Posted : August 26, 2021
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| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| COVID-19 | Drug: Resveratrol Dietary Supplement: Vitamin D3 | Phase 2 |
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.
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 100 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
| Primary Purpose: | Treatment |
| Official Title: | Randomized Double-Blind Placebo-Controlled Proof-of-Concept Trial of Resveratrol, a Plant Polyphenol, for the Outpatient Treatment of Mild Coronavirus Disease (COVID-19) |
| Actual Study Start Date : | September 12, 2020 |
| Actual Primary Completion Date : | March 1, 2021 |
| Actual Study Completion Date : | March 1, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: Resveratrol with Vitamin D3
Resveratrol 1000mg four times per day for 15 days. Vitamin D3 100,000 IU on day 1
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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. |
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Placebo Comparator: Placebo with Vitamin D3
Placebo capsules 4 times per day for 15 days. Vitamin D3 100,000 IU on day 1
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Dietary Supplement: Vitamin D3
Vitamin D3 100,000 IU given on day one. |
- Hospitalization rates for COVID-19 [ Time Frame: 21 days from study randomization ]Proportion of study participants admitted to the hospital within 21 days of randomization
- ICU Admission Rates [ Time Frame: 21 days from randomization ]Proportion of study participants admitted within 21 who subsequently get admitted to the ICU
- Invasive Ventilation Rates [ Time Frame: 21 days from randomization ]Proportion of study participants who get admitted with 21 day of randomization who receiving invasive ventilation.
- Pneumonia [ Time Frame: 21 days from randomization ]Proportion of study participants are diagnosed with pneumonia with 21 day of randomization
- Adverse events [ Time Frame: 60 days from randomization ]Diarrhea, nausea, abdominal cramping
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 45 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04400890
| United States, Ohio | |
| Mt Carmel HealthSystems | |
| Columbus, Ohio, United States, 43213 | |
| Principal Investigator: | Marvin R McCreary | Mount Carmel Health System |
Documents provided by Marvin McCreary, MD, Mount Carmel Health System:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Marvin McCreary, MD, Emergency Physician, Mount Carmel Health System |
| ClinicalTrials.gov Identifier: | NCT04400890 |
| Other Study ID Numbers: |
McCreary2020 |
| First Posted: | May 26, 2020 Key Record Dates |
| Last Update Posted: | August 26, 2021 |
| Last Verified: | August 2021 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | Yes |
| Supporting Materials: |
Study Protocol Clinical Study Report (CSR) |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Coronavirus SARS-CoV-2 COVID Vitamin D3 Cholecalciferol |
Supplement Polyphenol Resveratrol Stilbene phytoalexin |
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COVID-19 Respiratory Tract Infections Infections Pneumonia, Viral Pneumonia Virus Diseases Coronavirus Infections Coronaviridae Infections Nidovirales Infections RNA Virus Infections Lung Diseases Respiratory Tract Diseases Vitamin D |
Cholecalciferol Resveratrol Vitamins Micronutrients Physiological Effects of Drugs Bone Density Conservation Agents Calcium-Regulating Hormones and Agents Antioxidants Molecular Mechanisms of Pharmacological Action Protective Agents Enzyme Inhibitors Platelet Aggregation Inhibitors |