Covid19Phase 2NCT04604704
Pilot Study Into LDN and NAD+ for Treatment of Patients With Post-COVID-19 Syndrome
A Phase 2 study testing Naltrexone and NAD+ in people with Covid19 and Long COVID-19, run by AgelessRx at 1 site in United States.
Trial summary
Pilot study into low dose naltrexone (LDN) and NAD+ for treatment of patients with post-COVID-19 syndrome. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Covid19, Long COVID-19, Post-COVID-19 Syndrome
- What is being tested?
- Naltrexone and NAD+
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteUnited States
- Study dates
- 28 Jan 2021to 23 Jan 2023
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 test (polymerase chain reaction) result for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) 1-4 months before enrollment
- A fatigue score above 9 in the Chalder Fatigue scale upon enrollment
- Willing to fill out regular questionnaires
- Willing to use LDN and NAD patches
Who cannot join
- Clinically significant kidney, heart, Hepatic impairment as determined by clinical judgement
- Taking opioid analgesics, or undergoing treatment for opioid addiction
- Opioid dependence or withdrawal syndrome
- Known sensitivity to naltrexone
- Suspected or confirmed pregnancy or breastfeeding
- Known issues with using iontophoresis patches
Show all 9Show fewer
- Active cancers
- Enrolled in another trial
- Current users of LDN or NAD+
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Pilot Study Into Low Dose Naltrexone (LDN) and Nicotinamide Adenine Dinucleotide (NAD+) for Treatment of Patients With Post-COVID-19 Syndrome (Long-COVID19)
Pilot study into low dose naltrexone (LDN) and NAD+ for treatment of patients with post-COVID-19 syndrome.
Read the detailed description
This interventional pilot study will assess the use of low dose naltrexone (LDN) and NAD+ for the treatment of patients with post-COVID-19 syndrome (long-COVID-19).
Patients with a positive test for SARS-CoV-2 1-4 months before enrollment will be included. Subjects should have self diagnosed post-COVID19 syndrome and experiencing persistent fatigue since positive test. Patients will be screened using the fatigue survey and cases with a moderate to severe score will be included.
Patients will receive LDN and NAD+ treatment for 12 weeks. In this study, fatigue and quality of life will be assessed using validated surveys. Surveys will be conducted at baseline (at the time of enrollments, before treatment), and at 2, 4, 8, and 12 weeks. The improvement of scores from baseline levels will be assessed.
- Conditions
- Covid19, Long COVID-19, Post-COVID-19 Syndrome
- Being tested
- Naltrexone, NAD+
- Keywords
- COVID-19, Long COVID-19, Post-COVID-19 syndrome, naltrexone, NAD, Nicotinamide adenine dinucleotide, low dose naltrexone, LDN
- Medical subject headings
- COVID-19, Post-Acute COVID-19 Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NaltrexoneDrug
Also called Low dose Naltrexone (LDN)
Naltrexone at 4.5 mg/day
NAD+Dietary supplement
Also called Nicotinamide adenine dinucleotide
NAD+ will be applied using iontophoresis patches. The patches will be provided by ready-made NAD+ solutions (400 mg) to be applied to the positive electrode of the patch and saline to the negative electrode. The patch is powered by a self-contained battery, producing an electric current to facilitate NAD+ absorption through the skin into the blood. Patches are worn for 4-6 hours once a week.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with LDN and NAD+ | Experimental | LDN will be used at a dosage of 4.5 mg/day, which will be taken orally in the form of tablets. NAD+ will be administered using the IontoPatch iontophoresis patch containing 400 mg of NAD+ solution which is worn on the skin for 4-6 hours once per week. Receives: Drug: Naltrexone; Dietary Supplement: NAD+ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Reduction of fatigue in post-COVID-19 syndrome by treatment with LDN and NAD+
Reduction of fatigue score from baseline as measured by the Chalder fatigue scale in post-COVID-19 syndrome by treatment with LDN and NAD+. The Chalder scale has a minimum value of 0 and a maximum value of 33, and the higher the score the more severe the fatigue symptoms are.
Measured: 12 weeks
Secondary outcomes (1)
Improvement of quality of life in post-COVID-19 syndrome by treatment with LDN and NAD+.
Improvement of quality of life scores from baseline as measured by the short form-36 (SF-36) survey in post-COVID-19 syndrome by treatment with LDN and NAD+. The SF-36 survey provides scores between 0-100 with lower scores representing more disability.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Oct 2020
- Study start28 Jan 2021
- Primary completion23 Jan 2023
- Study completion23 Jan 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Patients will receive LDN and NAD+ treatment for 12 weeks. The researchers will assess fatigue and quality of life using validated surveys. Surveys will be conducted at baseline (at time of enrollments, before treatment), and at 2, 4, 8, and 12 weeks. Improvement of scores from baseline levels will be determined.
- Masking
- None (open label)
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- AgelessRx
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Sajad Zalzala, MD, Study director, AgelessRxSajad Zalzala, MD, Principal investigator, AgelessRx
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04604704
- Sponsor's protocol ID
- ALRx004
- Status last verified
- Jan 2023
- First submitted
- 26 Oct 2020
- Last updated
- 25 Jan 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study Into Low Dose Naltrexone (LDN) and Nicotinamide Adenine Dinucleotide (NAD+) for Treatment of Patients With Post-COVID-19 Syndrome (Long-COVID19)
- ClinicalTrials.gov ID
- NCT04604704
- Acronym / sponsor ID
- ALRx004
- Conditions
- Covid19, Long COVID-19, Post-COVID-19 Syndrome
- Keywords
- COVID-19, Long COVID-19, Post-COVID-19 syndrome, naltrexone, NAD, Nicotinamide adenine dinucleotide, low dose naltrexone, LDN
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- AgelessRxIndustry (pharma, biotech, devices)
- Study start
- 28 Jan 2021 (actual)
- Primary completion
- 23 Jan 2023 (actual)
- Study completion
- 23 Jan 2023 (actual)
- First posted
- 27 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Pilot study into low dose naltrexone (LDN) and NAD+ for treatment of patients with post-COVID-19 syndrome.
Detailed description
This interventional pilot study will assess the use of low dose naltrexone (LDN) and NAD+ for the treatment of patients with post-COVID-19 syndrome (long-COVID-19).
Patients with a positive test for SARS-CoV-2 1-4 months before enrollment will be included. Subjects should have self diagnosed post-COVID19 syndrome and experiencing persistent fatigue since positive test. Patients will be screened using the fatigue survey and cases with a moderate to severe score will be included.
Patients will receive LDN and NAD+ treatment for 12 weeks. In this study, fatigue and quality of life will be assessed using validated surveys. Surveys will be conducted at baseline (at the time of enrollments, before treatment), and at 2, 4, 8, and 12 weeks. The improvement of scores from baseline levels will be assessed.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Patients will receive LDN and NAD+ treatment for 12 weeks. The researchers will assess fatigue and quality of life using validated surveys. Surveys will be conducted at baseline (at time of enrollments, before treatment), and at 2, 4, 8, and 12 weeks. Improvement of scores from baseline levels will be determined.
| Arm | Type | Receives |
|---|---|---|
| Treatment with LDN and NAD+ | Experimental | Drug: Naltrexone, Dietary Supplement: NAD+LDN will be used at a dosage of 4.5 mg/day, which will be taken orally in the form of tablets. NAD+ will be administered using the IontoPatch iontophoresis patch containing 400 mg of NAD+ solution which is worn on the skin for 4-6 hours once per week. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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 test (polymerase chain reaction) result for SARS-CoV-2 (severe acute respiratory syndrome coronavirus 2) 1-4 months before enrollment
- A fatigue score above 9 in the Chalder Fatigue scale upon enrollment
Key exclusion criteria (9 listed)
- Clinically significant kidney, heart, Hepatic impairment as determined by clinical judgement
- Taking opioid analgesics, or undergoing treatment for opioid addiction
- Opioid dependence or withdrawal syndrome
- Known sensitivity to naltrexone
- Suspected or confirmed pregnancy or breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NaltrexoneAlso: Low dose Naltrexone (LDN)Naltrexone at 4.5 mg/day | Drug | Treatment with LDN and NAD+ |
| NAD+Also: Nicotinamide adenine dinucleotideNAD+ will be applied using iontophoresis patches. The patches will be provided by ready-made NAD+ solutions (400 mg) to be applied to the positive electrode of the patch and saline to the negative electrode. The patch is powered by a self-contained battery, producing an electric current to facilitate NAD+ absorption through the skin into the blood. Patches are worn for 4-6 hours once a week. | Dietary supplement | Treatment with LDN and NAD+ |
Primary outcome
Reduction of fatigue in post-COVID-19 syndrome by treatment with LDN and NAD+
Time frame: 12 weeks
Reduction of fatigue score from baseline as measured by the Chalder fatigue scale in post-COVID-19 syndrome by treatment with LDN and NAD+. The Chalder scale has a minimum value of 0 and a maximum value of 33, and the higher the score the more severe the fatigue symptoms are.
1 secondary outcome
Improvement of quality of life in post-COVID-19 syndrome by treatment with LDN and NAD+.
Time frame: 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jan 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Sajad Zalzala, MD study director
AgelessRx
Sajad Zalzala, MD principal investigator
AgelessRx
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Naltrexone and NAD+ in people with Covid19 and Long COVID-19, run by AgelessRx at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reduction of fatigue in post-COVID-19 syndrome by treatment with LDN and NAD+ (time frame: 12 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jan 2023.