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Virus Therapy

Q-GRFT Nasal Spray for COVID-19

Phase 1
Waitlist Available
Led By Sharon L Hillier, PhD
Research Sponsored by Sharon Hillier
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up approximately 28 days
Awards & highlights

Study Summary

This trial is testing a new drug to see if it is safe for humans. The drug will be given to adults through a nasal spray, and they will be monitored for side effects. If the drug is safe, participants will use it for 13 more days. The trial will last for 6-8 weeks total.

Eligible Conditions
  • COVID-19
  • Coronavirus
  • Pharmacokinetics
  • Safety

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~approximately 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and approximately 28 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Related Grade 2 or Higher Adverse Events
Secondary outcome measures
Acceptability of the Intranasal Spray
Area Under the Plasma Concentration Versus Time Curve of Q-GRFT
Q-GRFT Concentration From Nasopharyngeal Swab Eluent Collected at 24 Hours
+1 more
Other outcome measures
Mean Change in Brief Smell Identification Test (BSIT) Score
Q-GRFT Concentration From Nares Swab Eluent Collected at 24 Hours
Q-GRFT Concentration From Nares Swab Eluent Collected at 24 Hours After 13 Consecutive Daily Intranasal Applications
+2 more

Trial Design

2Treatment groups
Active Control
Placebo Group
Group I: Q-GRFT Nasal SprayActive Control1 Intervention
Q-Griffithsin (Q-GRFT) nasal spray (7.5mg/mL). Two metered doses of 100μL into each nostril, total of 3mg Q-GRFT per administration, administered once daily for 14 consecutive days.
Group II: Placebo Nasal SprayPlacebo Group1 Intervention
Placebo Nasal Spray. Two metered doses of 100μL into each nostril, administered once daily for 14 consecutive days.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Sharon HillierLead Sponsor
1 Previous Clinical Trials
480 Total Patients Enrolled
National Cancer Institute (NCI)NIH
13,654 Previous Clinical Trials
40,933,075 Total Patients Enrolled
39 Trials studying COVID-19
1,900,696 Patients Enrolled for COVID-19
Sharon L Hillier, PhDPrincipal InvestigatorUniversity of Pittsburgh
10 Previous Clinical Trials
2,183 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Has Q-GRFT Nasal Spray been bestowed with official sanction from the FDA?

"Due to the limited amount of data regarding both efficacy and safety, Q-GRFT Nasal Spray was given a score of 1 on our team's scale."

Answered by AI

How many participants will be admitted to this research project?

"Affirmative. Clinicaltrials.gov shows that this research has been open for recruitment since March 15th 2022, and was recently updated on the 31st of the same month. In total, 45 patients are needed from 2 sites to participate in this study."

Answered by AI

Is this trial open to participants over two decades of age?

"To be eligible for this trial, applicants must be aged between 18 and 55 years old. Separately, there are 142 studies geared towards those below the age of consent and 946 studies focusing on elderly patients above 65 years old."

Answered by AI

Is enrollment open for this particular clinical experiment?

"Affirmative. Clinicaltrials.gov stipulates that this medical research is actively recruiting patients, which began on March 15th 2022 and was recently updated at the end of the month. 45 participants across two sites are needed to complete the trial."

Answered by AI

Would I be eligible to join this medical experiment?

"This clinical trial is currently looking for 45 individuals aged 18 to 55 years old who have a confirmed diagnosis of COVID-19. Additionally, all potential participants should meet the following requirements: males must use male condoms or be sterilized/partner using hormonal contraception; identify as MSM and agree to abstain from sexual activity for 60 days prior to and during the study duration; provide written informed consent; in general good health according to site clinician; negative SARS-CoV-2 test at screening with full vaccination (not including boosters); no other investigational drugs used within this period; no nasally administered products such as OTC"

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Safety and Acceptability of Q GRFT Nasal Spray for COVID-19 Prophylaxis
Sharon Hillier 2022. "Safety and Acceptability of Q GRFT Nasal Spray for COVID-19 Prophylaxis". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05180500.
~16 spots leftby Apr 2025
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