Covid19
Conditions
Keywords
metformin, LDN, low dose naltrexone, COVID-19
Brief summary
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.
Detailed description
The researchers will treat 40 patients with metformin (1500 mg/day) and LDN (4.5 mg/day) for 4 weeks to reduce symptoms, disease severity, and recovery time from COVID-19. These 40 patients will be compared with 40 control patients who will receive regular care. All patients will be asked to complete surveys at baseline and after 1, 2, and 4 weeks after initiation of treatment. The difference with baseline at each time point will be assessed. The surveys will assess COVID-19 symptoms severity.
Interventions
DRUGMetformin
Metformin at 1500 mg/day
DRUGNaltrexone
Naltrexone at 4.5 mg/day (LDN)
Sponsors
AgelessRx
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
30 Years to 70 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Reduction of COVID-19 symptoms after 1 week of treatment with metformin and LDN | 1 week | 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'. |
| Reduction of COVID-19 symptoms after 2 weeks of treatment with metformin and LDN | 2 weeks | 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'. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Reduction in recovery time from COVID-19 | 4 weeks | Reduction in the number of days with symptoms due to COVID-19 upon treatment with metformin and LDN, compared to placebo group |
| Reduction in hospitalizations | 4 weeks | Reduction in the number of patients being hospitalized due to COVID-19 upon treatment with metformin and LDN, compared to placebo group |
| Reduction in requirement of additional treatment due to COVID-19 | 4 weeks | Reduction in the number of patients requiring additional treatment for COVID-19 upon treatment with metformin and LDN, compared to placebo group |
| Reduction in mortality | 4 weeks | Reduction in the number of mortality cases due to COVID-19 upon treatment with metformin and LDN, compared to placebo group |
Countries
United States
Outcome results
None listed