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Virus Therapy

Group 2 for COVID-19

Phase 1

Recruiting

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

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 day 1 - day 28

Awards & highlights

Study Summary

This trial is testing the safety, tolerability, and how the body processes a new drug called SLV213 in healthy adults. The study will help determine the best dose of SLV213 for treating

Who is the study for?

This trial is for healthy men and women aged 18-65 who can take oral medication, follow the dosing schedule, and are willing to use contraception or practice true abstinence. Participants should have stable vital signs and normal ECGs. Those with certain acceptable lab values may join except for specific liver function tests.Check my eligibility

What is being tested?

The study is testing SLV213's safety by giving different doses (400 mg, 600 mg, and 800 mg every 12 hours) compared to a placebo over seven days. It's a Phase 1 trial where participants are randomly assigned into groups in three sequential cohorts to find the maximum tolerated dose.See study design

What are the potential side effects?

Since this is a Phase 1 trial primarily focused on safety, detailed side effects of SLV213 aren't listed but will be closely monitored throughout the study.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 - day 28

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 - day 28

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 - day 28 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Incidence of ECG adverse events (AEs)

Incidence of ECG serious adverse events (SAEs)

Incidence of laboratory adverse events (AEs)

+27 more

Secondary outcome measures

Accumulation ratio for area under the plasma concentration-time curve (RAUC) following multiple-dose of SLV213

Accumulation ratio for maximum observed plasma concentration (RCmax) following multiple-dose of SLV213

Area under the plasma concentration-time curve (AUC) from 0h (pre-dose) to 12h after dosing (AUC0-12) following single-dose of SLV213

+25 more

Trial Design

3Treatment groups

Experimental Treatment

Group I: Group1Experimental Treatment2 Interventions

400mg (4x 100mg capsules) of SLV213 (N=8) or placebo (N=4) administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.

Group II: Group 3Experimental Treatment2 Interventions

800mg (8x 100mg capsules) of SLV213 (N=8) or placebo (N=4) administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.

Group III: Group 2Experimental Treatment2 Interventions

600mg (6x 100mg capsules) of SLV213 (N=8) or placebo (N=4) administered orally every 12 hours for 7 days to healthy male and female participants 18-65 years of age.

Do I qualify?Apply below to find out

Find a Location

Logistics

Participation is compensated

You will be compensated for participating in this trial.

Who is running the clinical trial?

National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor

3,270 Previous Clinical Trials

5,485,201 Total Patients Enrolled

78 Trials studying COVID-19

292,172 Patients Enrolled for COVID-19

Frequently Asked Questions

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

Is the clinical trial accepting individuals younger than 20 years old?

"To be eligible for this research study, individuals must meet the age requirements of being at least 18 years old and no more than 65 years old."

Answered by AI

Are there any available positions for patients to participate in this clinical trial?

"As documented on clinicaltrials.gov, the ongoing recruitment of participants for this trial continues. The initial posting of the clinical trial occurred on March 8th, 2024, with the most recent update being made on March 14th, 2024."

Answered by AI

What is the current participation count in this clinical trial?

"Indeed, the details on clinicaltrials.gov suggest that this study is actively seeking volunteers. The trial was initially posted on March 8th, 2024, and last revised on March 14th, 2024. Recruitment aims to enroll a total of 36 participants at one designated site."

Answered by AI

Has Group1 received official approval from the FDA?

"Based on our evaluation at Power, Group1 has been rated a 1 in terms of safety. This rating stems from the trial being classified as Phase 1, indicating there is scarce supporting data for both safety and effectiveness."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Safety Study of SLV213 for the Treatment of COVID-19.

2024. "Safety Study of SLV213 for the Treatment of COVID-19.". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06146374.

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