COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT04428073

Frank Tung, Ph.D

info@genecure.com

2020-06-11

Unknown

nonRCT

Non-randomized

Sequential assignment

Open label

unclear

Treatment

inclusion criteria: 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.

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.

2

GeneCure Biotechnologies

18

60

None

Infected patients

N/A

32

To evaluate the safety of a therapeutic Covid-19 vaccine in participants by measuring the severity of local and systemic adverse events and laboratory abnormalities.

None

Phase 1

[{"arm_notes": "low dose;1mL;2;weeks0-2", "treatment_id": 335, "treatment_name": "Covax-19", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "high dose;1mL;2;weeks0-2", "treatment_id": 335, "treatment_name": "Covax-19", "treatment_type": "Protein subunit", "pharmacological_treatment": "Vaccine"}]