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Therapeutic Biologics

COVID-19 Therapeutic Biologic for COVID-19 (COV19-APTP-B Trial)

Phase < 1
Waitlist Available
Research Sponsored by Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB Chair
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) > 93% on room air at sea level, heart rate ≥ 90 beats per minute
No clinical signs indicative of Severe or Critical Illness Severity
Must not have
Severe or Critical Illness Severity
Serious Bleed Tendency
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration at least 28 days
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing if a drug can help patients with COVID-19 by activating the body's response to the virus.

Who is the study for?
This trial is for people with moderate COVID-19 confirmed by standard tests, experiencing symptoms like shortness of breath or increased heart rate. They must have an oxygen saturation over 93% without assistance and not be severely ill. Pregnant or breastfeeding individuals, those with serious illnesses, allergies, bleeding tendencies, or prohibited from using biologics cannot join.
What is being tested?
The study is testing a new therapeutic biologic called Spike-GM-CSF Protein in a solution known as Lactated Ringer's Injection to see if it can help the body's immune cells fight off COVID-19 more effectively by targeting multiple virus strains.
What are the potential side effects?
Potential side effects may include reactions at the injection site, flu-like symptoms such as fever and chills, fatigue, headache and possible allergic responses due to activation of the immune system.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have COVID-19 with symptoms like fast breathing, oxygen level above 93%, and heart rate over 90.
Select...
I do not have signs of severe or critical illness.
Select...
I have moderate COVID-19 symptoms.
Select...
I experience shortness of breath with exertion due to COVID-19.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My condition is severe or critical.
Select...
I have a serious tendency to bleed.
Select...
I am not using any biological products.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration at least 28 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and duration at least 28 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Concentration of Active Ingredient
Number of Participants with Moderate COVID-19
Rate of Negative COVID-19 nucleic acid
+1 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Assess for therapeutic biologics activity (proof-of-concept)Experimental Treatment1 Intervention
* 0.1mg Spike-GM-CSF Protein * 0.5 ml Lactated Ringer's Injection, USP

Find a Location

Who is running the clinical trial?

PPD DEVELOPMENT, LPIndustry Sponsor
163 Previous Clinical Trials
37,295 Total Patients Enrolled
Han Xu, M.D., Ph.D., Sponsor-Investigator, IRB ChairLead Sponsor
3 Previous Clinical Trials
1,220 Total Patients Enrolled
Han Xu, M.D., Ph.D., FAPCR, Sponsor-Investigator, IRB ChairLead Sponsor
5 Previous Clinical Trials
2,420 Total Patients Enrolled
PPDIndustry Sponsor
161 Previous Clinical Trials
36,371 Total Patients Enrolled
HAN XU, M.D., Ph.D.Study ChairMedicine Invention Design, Inc. (MIDI) - IORG0007849
3 Previous Clinical Trials
1,220 Total Patients Enrolled

Media Library

COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection (Therapeutic Biologics) Clinical Trial Eligibility Overview. Trial Name: NCT03305341 — Phase < 1
Coronavirus Research Study Groups: Assess for therapeutic biologics activity (proof-of-concept)
Coronavirus Clinical Trial 2023: COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection Highlights & Side Effects. Trial Name: NCT03305341 — Phase < 1
COVID-19 Therapeutic Biologics - Spike-GM-CSF Protein Lactated Ringer's Injection (Therapeutic Biologics) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03305341 — Phase < 1
~4 spots leftby Dec 2025
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