Q-Griffithsin 6.0 for Coronavirus Prevention

Phase 1

Waitlist Available

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

No Placebo-Only Group

Summary

This trial tests a special nasal spray called Q-GRFT in healthy volunteers. The spray is designed to prevent COVID-19 and other coronaviruses by blocking them in the nose. The study aims to ensure the spray is safe for use.

Eligible Conditions

Coronavirus Prevention

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 0, 6 or 7 (day 9)

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Safety of product by measuring number of subjects that experience Adverse Events greater than Grade 3.

Secondary study objectives

Acceptability

Anti-drug antibody levels

Pharmacokinetic levels

+2 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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.

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