COVID-19 trials registries data warehouse

http://en.irct.ir/trial/68357

Somaye Dehghanizadeh

contact@renap.ir

2023-02-07

Completed

RCT

Randomized

Parallel

Blind label

single-center

Prevention

Provides written informed consent prior to initiation of any study procedures Be able to understand the purpose and risks of the study and willing and able to comply with planned study procedures and be available for all study visits Agrees to perform all study procedures, including the collection of venous blood per protocol 18 to 50 years of age, inclusive Body Mass Index 18-35 kg/m2 Women of childbearing potential must agree to use a reliable method of contraception from the time of enrollment until sixty days after receiving the intervention and negative urine or serum pregnancy test within 24 hours prior to intervention administration Male subjects of childbearing potential with a female partner of childbearing potential agree to use effective contraception from intervention through 60 days after Male subjects agree to refrain from sperm donation from the time of intervention through 60 days after In good health as determined by medical history and physical examination and the opinion of the principal investigator Has received 3 doses of inactivated Sinopharm or COVIran Barekat vaccine and the time interval from receiving the last dose of vaccine to receiving clinical study intervention at least 90 days and maximum 18 months, vaccination history must be checked and approved through the vaccination record Normal vital signs at the screening visit and at the time of intervention including: temperature less than 38.0 °C; pulse no greater than 100 beats per minute; systolic blood pressure 90 to 140 mmHg and diastolic blood pressure 60 to 90 mmHg; Oxygen saturation≥ 95%; respiration rate 12 to 20 BPM Clinical screening laboratory evaluations (WBC, Hgb, PLTs, ALT, AST, BUN, Cr, ALP, T.Bili, Lipase, PT, PTT, TSH, T4, FBS, and CRP) are within acceptable normal reference ranges Agree to refrain from donating blood or plasma during the study (outside of this study)

Positive pregnancy test either at screening or just prior to intervention administration Female subject who is breastfeeding or plans to breastfeed from the time of intervention through 60 days after Has any medical disease or condition that, in the opinion of the principal investigator, precludes study participation Presence of self-reported or medically documented significant medical (including respiratory, cardiovascular, neurological, autoimmune, Immunodeficiency, and kidney diseases...) or psychiatric condition Has an acute illness within 2 weeks prior to injection, with or without fever [temperature ≥38.0°C], runny nose or eyes, shortness of breath, cough, weakness, and diarrhea, that in the opinion of the principal investigator, precludes study participation Has a positive test result for hepatitis B surface antigen, hepatitis C virus antibody, or HIV types 1 or 2 antibodies Has participated in another investigational study involving any investigational product (study drug, biologic, or device) within 60 days, or 5 half-lives, whichever is longer, before intervention administration Currently enrolled in or plans to participate in another clinical trial during the study period Has previously participated in an investigational study involving lipid nanoparticles (LNPs) Has a history of hypersensitivity or severe allergic reaction (e.g., anaphylaxis, generalized urticaria, angioedema, other significant reaction) to any components of the study product, any previous licensed or investigational vaccines or medication, and to any food or cosmetics History of using any medication that, in the opinion of the principal investigator or the study pharmacotherapist, may be associated with impaired immune responsiveness Anticipating the need for immunosuppressive treatment within Within 6 months after study enrollment Received immunoglobulins and/or any blood or blood products within the 4 months before intervention administration or the possible need to use at any time during the study Has any blood dyscrasias or significant disorder of coagulation Has any chronic liver disease, including fatty liver Has a history of alcohol abuse or other recreational drug use within 6 months before intervention administration Has a positive test result for drugs of abuse at screening Has any abnormality or permanent body art (e.g., tattoo) that would interfere with the ability to observe local reactions at the injection site (deltoid region) Received or plans to receive a licensed, live vaccine within 4 weeks before or after intervention administration Received or plans to receive a licensed, inactivated vaccine within 2 weeks before or after intervention administration History of clinical or virological diagnosis of COVID-19 within 3 months before intervention administration Positive SARS-CoV-2 or influenza PCR test from nasopharyngeal swab at the screening visit, with a maximum time interval of 48 hours between taking the test and intervention administration History of receiving medication to prevent COVID-19 within 3 months before intervention administration On current treatment with investigational agents for prophylaxis of COVID-19 Current use of any prescription or over-the-counter medications within 7 days prior to intervention administration, unless approved by the investigator or necessary to manage a chronic condition Bleeding diathesis or condition associated with prolonged bleeding that would, in the opinion of the investigator, contraindicate intramuscular injection Plan to travel outside Iran from enrollment through 28 days after intervention administration Reside in a nursing home or other skilled nursing facility or have a requirement for skilled nursing care Non-ambulatory Recent (within the last 12 months) use of a dermal filler History of thrombosis Vulnerable groups and foreigners

3

ReNAP Company

18

50

Iran

Healthy volunteers

N/A

30

Reactogenicity Frequency and grade of each solicited local and systemic adverse event Frequency and grade of any unsolicited AEs Frequency of Serious Adverse Events (SAEs) Frequency of New Onset Chronic Medical Conditions (NOCMCs) Frequency of Medically Attended Adverse Event (MAAEs)

Phase 1

[{"arm_notes": "25 \u03bcg", "treatment_id": 2689, "treatment_name": "Corenapcin vaccine", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "50 \u03bcg", "treatment_id": 2689, "treatment_name": "Corenapcin vaccine", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]