Status:
UNKNOWN
Therapeutic Vaccine Trial of COVID-19 for Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) Infection
Lead Sponsor:
GeneCure Biotechnologies
Conditions:
COVID
Eligibility:
All Genders
18-60 years
Phase:
PHASE1
Brief Summary
GC004 is a Phase I trial to evaluate the safety and the immune responses of a therapeutic vaccine in SARS-CoV-2 infected patients. Covid-19 confirmed patients with mild or no symptoms will be enrolled...
Eligibility Criteria
Inclusion
- Documentation of Covid-19 infection based on laboratory evidence of positivity by RT- PCR.
- Patients who have no clinical symptoms (fever, cough and dyspnea).
- Patients who have mild clinical symptoms that could include fever, cough, sore throat, malaise, headache, muscle pain, gastrointestinal symptoms, without shortness of breath (dyspnea).
- Screening laboratory values within institutional normal range or judged to be not clinically significant by clinical investigator.
- Ability and willingness of subject to give written informed consent.
- Negative pregnancy test on the day prior to each vaccination.
- Willingness to use adequate contraception by study participants.
Exclusion
- History of respiratory and cardiovascular diseases, hematologic disease (e.g., cryoglobulinemia, lymphoma), renal disease, dermatologic disease (e.g., lichen planus, porphyria cutanea tarda).
- Autoimmune diseases or clinically serious cardiac, pulmonary, gastrointestinal, hepatic, renal or neurologic disease, which in the opinion of the investigator will compromise ability to participate in the study.
- Pregnancy and breast-feeding.
- Prior or current systemic cancer chemotherapy.
- Investigational agents and immunomodulators (cyclosporine, hematological growth factors, systemic corticosteroids, interleukins or interferons) within 90 days prior to study entry.
- Anaphylaxis or allergy to vaccine components.
- Active drug or alcohol use or dependence that, in the opinion of the investigator, would interfere with adherence to study requirements.
- Any other serious diseases other than Covid-19 infection including current or recent (within 5 years) cancers.
- Subjects who are immunocompromised or immunosuppressed due to disease or medications.
- Women who are lactating.
Key Trial Info
Start Date :
July 1 2020
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2021
Estimated Enrollment :
32 Patients enrolled
Trial Details
Trial ID
NCT04428073
Start Date
July 1 2020
End Date
December 1 2021
Last Update
June 11 2020
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