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Active Arm, Zota Cohort 2 for Coronavirus

Pinnacle Research Group, Anniston, AL
Zotatifin +1 morePhase 1Waitlist AvailableResearch Sponsored by Effector Therapeutics

Study Summary

This trial is testing a new drug to see if it is safe and effective against mild or moderate cases of COVID-19.

Eligible Conditions
  • Coronavirus

Eligibility Criteria

Inclusion Criteria

You will be eligible if you check “Yes” for the criteria below
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You have at least two symptoms commonly associated with COVID-19, like fever, cough, tiredness, or sore throat. These symptoms started no more than 5 days ago and your condition is not severe.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~52 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 52 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
Safety as assessed by the incidence of Treatment Emergent Adverse Events and Serious Adverse Events
Safety as assessed by the incidence of adverse events of special interest
Tolerability as assessed by changes in clinical laboratory tests from baseline (Day 1)
+2 more
Secondary outcome measures
Mean change in SARS-CoV-2 viral load;
Proportion of patients with SARS-CoV-2 viral load below the level of detectability;
The time to clinical resolution;
+2 more
Other outcome measures
Assessment and quantification of infectious virus
Change in the WHO 9-point ordinal scale for clinical improvement
Mean change in viral load in plasma
+4 more

Trial Design

4Treatment groups
Active Control
Placebo Group
Group I: Active Arm, Zota Cohort 2Active Control1 Intervention
0.02 mg/kg zotatifin
Group II: Active Arm, Zota Cohort 3Active Control1 Intervention
0.035 mg/kg zotatifin
Group III: Active Arm, Zota Cohort 1Active Control1 Intervention
0.01 mg/kg zotatifin
Group IV: PlaceboPlacebo Group1 Intervention
5% dextrose injection, USP

Find a site

Who is running the clinical trial?

Effector TherapeuticsLead Sponsor
9 Previous Clinical Trials
437 Total Patients Enrolled
Medpace, Inc.Industry Sponsor
91 Previous Clinical Trials
28,878 Total Patients Enrolled
Douglas Warner, MDStudy Director
eFFECTOR Therapeutics, Inc.
2 Previous Clinical Trials
210 Total Patients Enrolled
Premal Patel, MD, MPHStudy Director
eFFECTOR Therapeutics, Inc.
Robert Sikorski, MD, PhDStudy Director
Effector Therapeutics
1 Previous Clinical Trials
30 Total Patients Enrolled

Frequently Asked Questions

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

Does this research project involve elderly participants?

"This study is looking for 18 to 64-year-old patients that meet the inclusion criteria. Out of the 1,147 ongoing clinical trials, 150 are for minors and 997 are for seniors."

Answered by AI

Are there other published papers that feature Active Arm, Zota Cohort 2?

"As of right now, there are 2 ongoing clinical trials studying Active Arm, Zota Cohort 2. 0 of these trials are in Phase 3. Although many of the trials are based in Cullman, Alabama, there are a total of 19 clinical trial sites for Active Arm, Zota Cohort 2."

Answered by AI

How many subjects are enroled in this research project?

"36 individuals that meet the pre-determined inclusion criteria must enroll in this clinical trial. These potential participants can reside near Pinnacle Research Group in Anniston, Maryland or National Institute of Allergy and Infectious Diseases in Bethesda, Florida."

Answered by AI

What precedent does this trial set for future research?

"As of now, there are 2 ongoing trials for Active Arm, Zota Cohort 2 in 17 metropolises and 1 nation. The first research project for Active Arm, Zota Cohort 2 was in 2019. The 198 participants completed Phase 1 & 2 drug approval. Since then, 18244 other trials have been completed."

Answered by AI

Are there different facilities testing this procedure within the state?

"There are a total of 7 research sites running this study, including Pinnacle Research Group in Anniston, National Institute of Allergy and Infectious Diseases in Bethesda, and National Institutes of Health Clinical Center in Bradenton."

Answered by AI

Are we looking for participants in this experiment currently?

"Yes, this is an active recruitment according to the information on clinicaltrials.gov. This trial was posted on 7/1/2021 and was last edited on 10/5/2022. They are recruiting for 36 patients at 7 locations."

Answered by AI

Who can sign up for this experiment?

"Eligible individuals for this study must suffer from a virus disease, be aged 18-64, and there are only 36 total spots open."

Answered by AI

Has Active Arm, Zota Cohort 2 received FDA approval?

"Active Arm, Zota Cohort 2 falls into the Phase 1 category, which means that, according to our team's estimation, it ranks a 1 on the safety scale."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Intravenous Zotatifin in Adults With Mild or Moderate COVID-19
2021. "Intravenous Zotatifin in Adults With Mild or Moderate COVID-19". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04632381.
~11 spots leftby Sep 2024
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