Q-GRFT Nasal Spray for Coronavirus

Phase-Based Progress Estimates
1
Effectiveness
1
Safety
Coronavirus+7 MoreQ-Griffithsin - Drug
Eligibility
18 - 55
All Sexes
What conditions do you have?
Select

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
  • Coronavirus
  • Safety
  • Pharmacokinetics

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

1 Primary · 5 Secondary · Reporting Duration: Approximately 28 days

Approximately 14 days
Mean Change in Brief Smell Identification Test (BSIT) Score
Q-GRFT Concentration from Nares Swab Eluent Collected at 24 Hours After 13 Consecutive Daily Intranasal Applications
Q-GRFT Concentration from Oropharyngeal Swab Eluent Collected at 24 Hours After 13 Consecutive Daily Intranasal Applications
Q-GRFT Concentration from Rectal Swab Eluent Collected at 24 Hours After 13 Consecutive Daily Intranasal Applications
Approximately 24 hours
Q-GRFT Concentration from Nares Swab Eluent Collected at 24 Hours
Q-GRFT Concentration from Nasopharyngeal Swab Eluent Collected at 24 Hours
Q-GRFT Concentration from Oropharyngeal Swab Eluent Collected at 24 Hours
Q-GRFT Plasma Concentration Collected at 24 Hours
Approximately 28 days
Acceptability of the Intranasal Spray
Area Under the Nasopharyngeal Swab Eluent Concentration versus Time Curve of Q-GRFT
Area Under the Plasma Concentration versus Time Curve of Q-GRFT
Approximately 8 weeks
Number of Participants with Related Grade 2 or Higher Adverse Events

Trial Safety

Safety Progress

1 of 3

Trial Design

2 Treatment Groups

Q-GRFT Nasal Spray
1 of 2
Placebo Nasal Spray
1 of 2

Active Control

Non-Treatment Group

50 Total Participants · 2 Treatment Groups

Primary Treatment: Q-GRFT Nasal Spray · Has Placebo Group · Phase 1

Q-GRFT Nasal Spray
Drug
ActiveComparator Group · 1 Intervention: Q-Griffithsin · Intervention Types: Drug
Placebo Nasal Spray
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: approximately 28 days

Who is running the clinical trial?

National Cancer Institute (NCI)NIH
13,085 Previous Clinical Trials
41,141,461 Total Patients Enrolled
Sharon HillierLead Sponsor
1 Previous Clinical Trials
480 Total Patients Enrolled
Sharon L Hillier, PhDPrincipal InvestigatorUniversity of Pittsburgh
10 Previous Clinical Trials
2,183 Total Patients Enrolled

Eligibility Criteria

Age 18 - 55 · All Participants · 9 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You are a man who has sex with men exclusively and/or sexually abstinent for the past 60 days and agree to remain abstinent for the duration of the study.
You have a negative SARS-CoV-2 test at screening.
You are fully vaccinated for SARS-CoV-2.