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Virus Therapy

Q-Griffithsin 6.0 for Coronavirus Prevention

Phase 1
Recruiting
Led By Gerald W Dryden, MD, PhD
Research Sponsored by Kenneth Palmer
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up visit 0, 6 or 7 (day 9)
Awards & highlights

Study Summary

This trial is testing the safety of a nasal spray that may help prevent the transmission of COVID-19.

Eligible Conditions
  • Coronavirus Prevention

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~visit 0, 6 or 7 (day 9)
This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 0, 6 or 7 (day 9) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Safety of product by measuring number of subjects that experience Adverse Events greater than Grade 3.
Secondary outcome measures
Acceptability
Anti-drug antibody levels
Pharmacokinetic levels
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Group I: Q-Griffithsin Group 2: two 3.0 mg sprays per dayExperimental Treatment1 Intervention
In Group 2, up to 12 participants will be enrolled to receive a total of 6.0 mg intranasal Q-GRFT administered as 3.0 mg twice daily (3.0 mg BID), with 2 sprays (100 µL/ spray) in each nostril approximately every 12 hours, for 7 days.
Group II: Q-Griffithsin Group 1: 3.0 mg daily sprayExperimental Treatment1 Intervention
In Group 1, up to 12 participants will receive a dose of 3.0 mg intranasal Q-GRFT administered once daily, as 2 sprays (100 µL/ spray) in each nostril, for 7 days.

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

Kenneth PalmerLead Sponsor
1 Previous Clinical Trials
18 Total Patients Enrolled
United States Department of DefenseFED
865 Previous Clinical Trials
327,675 Total Patients Enrolled
Gerald W Dryden, MD, PhDPrincipal InvestigatorUniversity of Louisville

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
American Journal of RhinologyJournal
Office Procedures for Quantitative Assessment of Olfactory Function
Doty, Richard L.. 2007. “Office Procedures for Quantitative Assessment of Olfactory Function”. American Journal of Rhinology. SAGE Publications. doi:10.2500/ajr.2007.21.3043.
The LaryngoscopeJournal
Development of the 12-item Cross-cultural Smell Identification Test(cc-sit)
Doty, Richard L., Avron Marcus, and W. William Lee. 1996. “Development of the 12-item Cross-cultural Smell Identification Test(cc-sit)”. The Laryngoscope. Wiley. doi:10.1097/00005537-199603000-00021.
Annals of Allergy, Asthma & ImmunologyJournal
Evaluating Quality of Life in Patients with Asthma and Rhinitis: English Adaptation of the Rhinasthma Questionnaire
Chen, Hubert, Miriam G. Cisternas, Patricia P. Katz, Theodore A. Omachi, Laura Trupin, Edward H. Yelin, John R. Balmes, and Paul D. Blanc. 2011. “Evaluating Quality of Life in Patients with Asthma and Rhinitis: English Adaptation of the Rhinasthma Questionnaire”. Annals of Allergy, Asthma & Immunology. Elsevier BV. doi:10.1016/j.anai.2010.10.027.
clinicaltrials.govStudy
Safety, Tolerability, and Pharmacokinetics of Q-Griffithsin Intranasal Spray
Kenneth Palmer 2022. "Safety, Tolerability, and Pharmacokinetics of Q-Griffithsin Intranasal Spray". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05437029.
~8 spots leftby Apr 2025
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