Kisspeptin for COVID-19

Overseen By Study Coordinator

Age: 18 - 65

Sex: Any

Trial Phase: Phase 1

Sponsor: Stephanie B. Seminara, MD

Must not be taking: Hormonal replacement

Disqualifiers: Excessive alcohol, Illicit drugs, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

Duration: 1 day

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how a treatment called kisspeptin affects individuals with and without post-COVID-19 syndrome. Researchers aim to determine how a single injection of kisspeptin impacts hormone levels. Participants will undergo frequent blood tests to monitor changes in hormone release before and after the treatment. The trial seeks individuals who have had COVID-19, with or without ongoing symptoms, who have normal blood pressure and have not recently used certain medications. As a Phase 1 trial, the research focuses on understanding how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.

Will I have to stop taking my current medications?

You may need to stop taking certain medications if they can affect the reproductive system, but the study team will decide this. If needed, you might have to go through a washout period (time without taking certain medications) before joining the trial.

Is there any evidence suggesting that kisspeptin is likely to be safe for humans?

Research has shown that kisspeptin is generally safe to use. In previous studies, researchers administered kisspeptin to people to observe its effects on certain hormones, and no major side effects were reported. Most people tolerate the treatment well, experiencing no serious problems.

Kisspeptin is now undergoing early research for conditions related to COVID-19. This phase primarily assesses safety, not efficacy for COVID-19. As this is the initial testing stage, information about its use for this specific purpose is limited. However, the focus on safety ensures that any risks are carefully monitored. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Kisspeptin is unique because it represents a novel approach to treating COVID-19 by potentially modulating the body's immune response. Most COVID-19 treatments, like antivirals and monoclonal antibodies, work by directly targeting the virus itself. However, kisspeptin, a naturally occurring peptide, may influence immune pathways and inflammation, which are critical in COVID-19 severity. This new mechanism of action is what excites researchers, as it could offer an alternative method of reducing symptoms and complications associated with the virus. Additionally, the administration of kisspeptin as a single bolus is straightforward, potentially simplifying treatment protocols.

What evidence suggests that kisspeptin might be an effective treatment for post-covid-19 syndrome?

Research has shown that kisspeptin might help the body fight viral infections. Some studies found higher levels of kisspeptin in people with certain viral infections, suggesting that it could assist the body in dealing with viruses. In this trial, participants will receive a single bolus of kisspeptin to explore its potential effects on recovery from COVID-19. Although no direct proof yet exists that kisspeptin can treat post-COVID-19 syndrome, its role in the immune response makes it an interesting area to explore. More research is needed to determine how kisspeptin affects recovery from COVID-19. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for adults with normal blood pressure and hemoglobin levels. Women (18-45) must not be pregnant or breastfeeding, and men (18-60) can participate too. Participants should not have used medications affecting the reproductive system recently, unless they agree to a washout period. It's specifically for those diagnosed with post-COVID syndrome or controls who've had COVID but no post-COVID syndrome.

Inclusion Criteria

Normal blood pressure (systolic BP < 140 mm Hg, diastolic < 90 mm Hg)

Hemoglobin no less than 0.5 g/dL below the lower limit of the sex-specific reference range

For women, negative serum hCG pregnancy test

Exclusion Criteria

Any condition that would likely interfere with participation in/completion of the protocol

Excessive alcohol consumption (>10 drinks/week)

Active use of illicit drugs

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Participants receive a single bolus of kisspeptin with frequent blood sampling every 10 minutes for 1-2 hours

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Kisspeptin

Trial Overview The study tests how kisspeptin affects LH secretion in people with and without long-term effects of COVID-19. Participants will receive one dose of kisspeptin intravenously, followed by frequent blood sampling every 10 minutes to monitor changes in hormone levels.

How Is the Trial Designed?

Group I: Kisspeptin administration Experimental Treatment 1 Intervention

Single bolus of kisspeptin

Who Is Running the Clinical Trial?

Stephanie B. Seminara, MD

Lead Sponsor

Trials

10

Recruited

840+

Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

Collaborator

Trials

2,103

Recruited

2,760,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11122271/

Clinical Features and Prognostic Predictors in Patients with ... This study examines the clinical outcomes and prognostic factors of COVID-19 in renal transplant recipients.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT07224490

Kisspeptin to Quantify GnRH Neuronal Function in Health ... 1-2 hours of q10 minute blood sampling. Administration of a single kisspeptin bolus in a dosing range of 0.313 - 13.19 μg/kg.

3. frontiersin.org frontiersin.org/journals/global-womens-health/articles/10.3389/fgwh.2022.866104/full

Chronic Stress and Ovulatory Dysfunction: Implications in ... On the contrary, signs of starvation and/or stress will inhibit the release of kisspeptin, affecting ovulation and the reproductive process. Functional ...

4. researchgate.net researchgate.net/publication/371323740_Study_of_serum_level_of_kisspeptin_and_interferon-beta_in_genital_wart_patients

Study of serum level of kisspeptin and interferon-beta in ... Results: Kisspeptin was significantly higher among cases than controls, whereas IFN-beta level was lower among cases than controls (P < 0.001).

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10343131/

Study of serum level of kisspeptin and interferon-beta in ... In line with our results, Huang et al.[12] revealed that, during viral infections, kisspeptin levels in mouse serum significantly rose. They discovered ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9868951/

Early and precocious puberty during the COVID-19 pandemic In CPP, treatment with GnRH agonist is considered safe, without significant adverse effects, and can be administered based on the progression of ...

7. withpower.com withpower.com/trial/phase-1-nerve-degeneration-11-2025-d4cca

Kisspeptin for COVID-19 · Info for Participants This trial is for adults with normal blood pressure and hemoglobin levels. Women (18-45) must not be pregnant or breastfeeding, and men (18-60) ...

8. mdpi.com mdpi.com/1422-0067/23/8/4275

Dissecting the Molecular Mechanisms Surrounding Post- ... With regards to the hypothalamic–kisspeptin network in PCS, hypogonadism and altered gonadotropin hormones levels have been observed in COVID-19 [105,106]. ...

9. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9620712/

The influence of COVID-19 infection-associated immune ... We hypothesize that the reported reproductive adverse effects are due to the robust immune reaction against COVID-19 and the associated cytokine storm.