Covid19 Clinical Trial
Official title:
Pilot Study Into the Use of Metformin and Low Dose Naltrexone (LDN) for Patients With Coronavirus Disease 2019 (COVID-19) - Assessment of Short and Long Term Effects
NCT number | NCT04604678 |
Other study ID # | ALRx003 |
Secondary ID | |
Status | Withdrawn |
Phase | Phase 2 |
First received | |
Last updated | |
Start date | February 2021 |
Est. completion date | October 2021 |
Verified date | October 2022 |
Source | AgelessRx |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Study into the effects of daily use of metformin and low-dose naltrexone (LDN) for 4 weeks to reduce symptoms, disease severity, and recovery time from COVID-19.
Status | Withdrawn |
Enrollment | 0 |
Est. completion date | October 2021 |
Est. primary completion date | August 2021 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 30 Years to 70 Years |
Eligibility | Inclusion Criteria: - Age 30-70 - Any sex - Any ethnicity - Adequate cognitive function to be able to give informed consent - Technologically competent to complete web forms and perform video calls with the PI - Positive PCR (polymerase chain reaction) test result for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) within the last 10 days - At least two COVID-19 symptoms as assessed by laboratory or patient self-reporting started within the last 3 days - Willing to fill out regular questionnaires - Willing to take metformin and LDN Exclusion Criteria: - Clinically significant hepatic, renal, or cardiac impairment (as determined by previous clinical judgement) - Hypoglycemia - Currently on drugs for COVID-19 - Hospitalization for COVID-19 - (Suspected) pregnancy or breastfeeding - Active cancer - Uncontrolled mental health issues - On any medication with major interactions with metformin or LDN - Taking opioid analgesics, or being treated for opioid addiction/recovery - Opioid dependence or withdrawal syndrome - Known sensitivity to metformin or naltrexone - Current users of metformin or naltrexone |
Country | Name | City | State |
---|---|---|---|
United States | AgelessRx | Ann Arbor | Michigan |
Lead Sponsor | Collaborator |
---|---|
AgelessRx |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Reduction of COVID-19 symptoms after 1 week of treatment with metformin and LDN | Reduction in COVID-19 symptoms as measured with the COVID-19 Symptoms Severity Scale. The scale has a minimum score of 0 and a maximum of 24, with values ranging from 4-11 are considered 'mild symptoms', scores ranging 12-19 are considered 'moderate', and scores 20-24 are considered 'severe'. | 1 week | |
Primary | Reduction of COVID-19 symptoms after 2 weeks of treatment with metformin and LDN | Reduction in COVID-19 symptoms as measured with the COVID-19 Symptoms Severity Scale. The scale has a minimum score of 0 and a maximum of 24, with values ranging from 4-11 are considered 'mild symptoms', scores ranging 12-19 are considered 'moderate', and scores 20-24 are considered 'severe'. | 2 weeks | |
Secondary | Reduction in recovery time from COVID-19 | Reduction in the number of days with symptoms due to COVID-19 upon treatment with metformin and LDN, compared to placebo group | 4 weeks | |
Secondary | Reduction in hospitalizations | Reduction in the number of patients being hospitalized due to COVID-19 upon treatment with metformin and LDN, compared to placebo group | 4 weeks | |
Secondary | Reduction in requirement of additional treatment due to COVID-19 | Reduction in the number of patients requiring additional treatment for COVID-19 upon treatment with metformin and LDN, compared to placebo group | 4 weeks | |
Secondary | Reduction in mortality | Reduction in the number of mortality cases due to COVID-19 upon treatment with metformin and LDN, compared to placebo group | 4 weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Completed |
NCT05047692 -
Safety and Immunogenicity Study of AdCLD-CoV19-1: A COVID-19 Preventive Vaccine in Healthy Volunteers
|
Phase 1 | |
Recruiting |
NCT04395768 -
International ALLIANCE Study of Therapies to Prevent Progression of COVID-19
|
Phase 2 | |
Completed |
NCT04506268 -
COVID-19 SAFE Enrollment
|
N/A | |
Completed |
NCT04508777 -
COVID SAFE: COVID-19 Screening Assessment for Exposure
|
||
Terminated |
NCT04555096 -
A Trial of GC4419 in Patients With Critical Illness Due to COVID-19
|
Phase 2 | |
Completed |
NCT04961541 -
Evaluation of the Safety and Immunogenicity of Influenza and COVID-19 Combination Vaccine
|
Phase 1/Phase 2 | |
Active, not recruiting |
NCT04546737 -
Study of Morphological, Spectral and Metabolic Manifestations of Neurological Complications in Covid-19 Patients
|
N/A | |
Terminated |
NCT04581915 -
PHRU CoV01 A Trial of Triazavirin (TZV) for the Treatment of Mild-moderate COVID-19
|
Phase 2/Phase 3 | |
Not yet recruiting |
NCT04543006 -
Persistence of Neutralizing Antibodies 6 and 12 Months After a Covid-19
|
N/A | |
Completed |
NCT04532294 -
Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2/COVID-19) Neutralizing Antibody in Healthy Participants
|
Phase 1 | |
Terminated |
NCT04542993 -
Can SARS-CoV-2 Viral Load and COVID-19 Disease Severity be Reduced by Resveratrol-assisted Zinc Therapy
|
Phase 2 | |
Completed |
NCT04494646 -
BARCONA: A Study of Effects of Bardoxolone Methyl in Participants With SARS-Corona Virus-2 (COVID-19)
|
Phase 2 | |
Completed |
NCT04507867 -
Effect of a NSS to Reduce Complications in Patients With Covid-19 and Comorbidities in Stage III
|
N/A | |
Completed |
NCT04537663 -
Prevention Of Respiratory Tract Infection And Covid-19 Through BCG Vaccination In Vulnerable Older Adults
|
Phase 4 | |
Completed |
NCT04387292 -
Ocular Sequelae of Patients Hospitalized for Respiratory Failure During the COVID-19 Epidemic
|
N/A | |
Not yet recruiting |
NCT04527211 -
Effectiveness and Safety of Ivermectin for the Prevention of Covid-19 Infection in Colombian Health Personnel
|
Phase 3 | |
Completed |
NCT04979858 -
Reducing Spread of COVID-19 in a University Community Setting: Role of a Low-Cost Reusable Form-Fitting Fabric Mask
|
N/A | |
Not yet recruiting |
NCT05038449 -
Study to Evaluate the Efficacy and Safety of Colchicine Tablets in Patients With COVID-19
|
N/A | |
Completed |
NCT04610502 -
Efficacy and Safety of Two Hyperimmune Equine Anti Sars-CoV-2 Serum in COVID-19 Patients
|
Phase 2 | |
Active, not recruiting |
NCT06042855 -
ACTIV-6: COVID-19 Study of Repurposed Medications - Arm G (Metformin)
|
Phase 3 |