Back to resultsPilot Study Into the Use of Metformin and LDN for Patients With COVID-19
Primary Purpose
Covid19
Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Metformin
Naltrexone
Sponsored by
About this trial
This is an interventional treatment trial for Covid19 focused on measuring metformin, LDN, low dose naltrexone, COVID-19
Eligibility Criteria
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
Sites / Locations
- AgelessRx
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
No Intervention
Arm Label
Treatment with Metformin and LDN
Regular health care comparison group
Arm Description
Patients will be treated with 1500 mg/day of metformin and 4.5 mg/day of LDN for a total of 4 weeks.
Patients will receive regular health care and will serve as a control group.
Outcomes
Primary Outcome Measures
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'.
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'.
Secondary Outcome Measures
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
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
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
Reduction in mortality
Reduction in the number of mortality cases due to COVID-19 upon treatment with metformin and LDN, compared to placebo group
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04604678
Brief Title
Pilot Study Into the Use of Metformin and LDN for Patients With COVID-19
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Unable to recruit participants due to restrictive inclusion/exclusion criteria. Will update protocol with IRB & begin anew after approval.
Study Start Date
February 2021 (Anticipated)
Primary Completion Date
August 2021 (Anticipated)
Study Completion Date
October 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AgelessRx
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Covid19
Keywords
metformin, LDN, low dose naltrexone, COVID-19
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment with Metformin and LDN
Arm Type
Experimental
Arm Description
Patients will be treated with 1500 mg/day of metformin and 4.5 mg/day of LDN for a total of 4 weeks.
Arm Title
Regular health care comparison group
Arm Type
No Intervention
Arm Description
Patients will receive regular health care and will serve as a control group.
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
Metformin at 1500 mg/day
Intervention Type
Drug
Intervention Name(s)
Naltrexone
Other Intervention Name(s)
LDN
Intervention Description
Naltrexone at 4.5 mg/day (LDN)
Primary Outcome Measure Information:
Title
Reduction of COVID-19 symptoms after 1 week of treatment with metformin and LDN
Description
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'.
Time Frame
1 week
Title
Reduction of COVID-19 symptoms after 2 weeks of treatment with metformin and LDN
Description
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'.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
Reduction in recovery time from COVID-19
Description
Reduction in the number of days with symptoms due to COVID-19 upon treatment with metformin and LDN, compared to placebo group
Time Frame
4 weeks
Title
Reduction in hospitalizations
Description
Reduction in the number of patients being hospitalized due to COVID-19 upon treatment with metformin and LDN, compared to placebo group
Time Frame
4 weeks
Title
Reduction in requirement of additional treatment due to COVID-19
Description
Reduction in the number of patients requiring additional treatment for COVID-19 upon treatment with metformin and LDN, compared to placebo group
Time Frame
4 weeks
Title
Reduction in mortality
Description
Reduction in the number of mortality cases due to COVID-19 upon treatment with metformin and LDN, compared to placebo group
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sajad Zalzala, MD
Organizational Affiliation
AgelessRx
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Sajad Zalzala, MD
Organizational Affiliation
AgelessRx
Official's Role
Principal Investigator
Facility Information:
Facility Name
AgelessRx
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48104
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Pilot Study Into the Use of Metformin and LDN for Patients With COVID-19
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