Pilot Study Into the Use of Metformin and LDN for Patients With COVID-19

Sponsor

AgelessRx (Industry)

Overall Status

Not yet recruiting

CT.gov ID

NCT04604678

Collaborator

(none)

Enrollment

Location

Arms

Anticipated Duration (Months)

10.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Covid19	Drug: Metformin Drug: Naltrexone	Phase 2

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

80 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

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

Anticipated Study Start Date :

Feb 1, 2021

Anticipated Primary Completion Date :

Aug 1, 2021

Anticipated Study Completion Date :

Oct 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Treatment with Metformin and LDN Patients will be treated with 1500 mg/day of metformin and 4.5 mg/day of LDN for a total of 4 weeks.	Drug: Metformin Metformin at 1500 mg/day Drug: Naltrexone Naltrexone at 4.5 mg/day (LDN) Other Names: LDN
No Intervention: Regular health care comparison group Patients will receive regular health care and will serve as a control group.

Arm

Intervention/Treatment

Experimental: Treatment with Metformin and LDN

Patients will be treated with 1500 mg/day of metformin and 4.5 mg/day of LDN for a total of 4 weeks.

Drug: Metformin

Metformin at 1500 mg/day

Drug: Naltrexone

Naltrexone at 4.5 mg/day (LDN)

Other Names:

LDN

No Intervention: Regular health care comparison group

Patients will receive regular health care and will serve as a control group.

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

30 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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