Long COVID, Neurodegeneration, Reproductive Disorder, SARS-CoV 2
Conditions
Keywords
Reproductive disorder, Neurodegeneration, SARS-CoV 2, Kisspeptin, Long COVID
Brief summary
The objective of this protocol is to use a case-control paradigm to compare the response to an intravenous administration of kisspeptin in individuals with and without post-covid-19 syndrome. The study subjects will receive a single bolus of kisspeptin.
Detailed description
Delivery of Interventions: * Administration of a single kisspeptin bolus in a dosing range of 0.313 - 13.19 μg/kg * Blood sampling before and after administration of kisspeptin (two timepoints total)
Interventions
Single bolus of kisspeptin
Sponsors
Stephanie B. Seminara, MD
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* Female (ages 18-45 years) or Male (ages 18-60 years) * No current or recent use of a medication (including hormonal replacement) that, in the opinion of a study investigator, can modulate the reproductive axis or willing to complete an appropriate washout for that particular medication and its method of administration * For women, negative serum hCG pregnancy test * For cases, diagnosis of post-covid-19 syndrome * For controls, history of prior covid infection but no diagnosis of post-covid-19 syndrome
Exclusion criteria
* Any condition (medical, mental, or behavioral) that, in the opinion of a study investigator, would likely interfere with participation in/completion of the protocol or the interpretation of results * Active use of illicit drugs (not including marijuana) * For women, * Pregnant * Trying to become pregnant during protocol participation * Breast feeding * Surgical or natural menopause
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Difference in mean luteinizing hormone (LH) amplitude between cases and controls | Day of study visit (one to two hours) | Difference between cases and controls of mean LH amplitude in response to kisspeptin |
Countries
United States
Contacts
CONTACTStudy Coordinator
Outcome results
None listed