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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up duration at least 28 days
Awards & highlights
COV19-APTP-B Trial 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.Check my eligibility
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.See study design
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.
COV19-APTP-B Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
COV19-APTP-B Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ duration at least 28 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~duration at least 28 days
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Concentration of Active Ingredient
Number of Participants with Moderate COVID-19
Rate of Negative COVID-19 nucleic acid
+1 moreCOV19-APTP-B 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
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Who is running the clinical trial?
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
159 Previous Clinical Trials
36,895 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You have another serious ongoing illness.I have COVID-19 with symptoms like fast breathing, oxygen level above 93%, and heart rate over 90.I do not have signs of severe or critical illness.My condition is severe or critical.You have a severe allergy.I have a serious tendency to bleed.I am not using any biological products.I have moderate COVID-19 symptoms.I experience shortness of breath with exertion due to COVID-19.You have tested positive for the virus using a standard RT-PCR test or a similar test.
Research Study Groups:
This trial has the following groups:- Group 1: Assess for therapeutic biologics activity (proof-of-concept)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
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