COVID-19 trials registries data warehouse

https://clinicaltrials.gov/show/NCT05398848

None

None

2022-06-01

Completed

RCT

Randomized

Parallel

Blind label

multi-center

Prevention

inclusion criteria: aged 18 years and older. able and willing to comply with all study requirements. willing to allow investigators to discuss the medical history with his/her general practitioner/personal doctors and access all medical records which are relevant to study procedures. healthy adults, or adults with stable medical condition who have a pre-existing medical condition that does not meet any exclusion criteria. a stable medical condition is defined as disease not requiring significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment. for females of childbearing potential only, willing to practice continuous effective contraception until 90 days after the final dose vaccination, and have negative pregnancy tests before each dose vaccination. nonchildbearing potential is defined as surgically sterile (history of bilateral tubal ligation, bilateral oophorectomy, hysterectomy) or postmenopausal. a follicle-stimulating hormone (fsh) level and the amenorrhea duration (e.g. amenorrhea for ≥ 12 consecutive months prior to screening without an alternative medical cause) may be measured at the discretion of investigator to confirm postmenopausal status. the effective contraceptive methods include sexual abstinence or adequate contraceptive measures such as intrauterine or implanted contraceptive device, oral contraceptives, injected or implanted contraceptives, sustained-release topical contraceptives, condoms (male), diaphragm, and cervical cap, etc. males participating in this study who are involved in heterosexual sexual activity must agree to practice adequate contraception (as described above) and refrain from donating sperm until 90 days after receiving the final dose vaccination. agreement to refrain from blood donation during the study. provide written informed consent form (icf) prior to study enrollment.

laboratory confirmed sars-cov-2 infection defined by rt-pcr assay at screening. participants with negative result for rapid antigen testing can be enrolled before having the result of rt-pcr assay, however, the participant needs to be withdrawn the following vaccination if the rt-pcr result shows positive. sars-cov-2 antibodies (igm or igg) positive at screening. medical history of severe acute respiratory syndrome (sars), middle east respiratory syndrome (mers) and covid-19 within 6 months prior to the randomization. fever (oral temperature ≥ 37.5°c / axillary temperature ≥ 37.3°c) on the day of vaccination or within recent 72 hours. history of severe allergic disease or reactions likely to be exacerbated by any component of recov, such as allergic shock, allergic laryngeal edema, allergic purpura, thrombocytopaenic purpura, local hypersensitive necrosis reaction (arthus reaction), or prior history of serious adverse reaction to any vaccine or drug, such as allergy, urticaria eczema, dyspnea, and angioneurotic edema. have malignant tumor (except for skin basal cell carcinoma or carcinoma uterine cervix in situ) and immune disease (e.g., documented human immunodeficiency virus [hiv] infection, systemic lupus erythematosus, rheumatoid arthritis, asplenia or splenectomy, and other immune disease that may influence immune response at investigator's discretion). have other severe and/or uncontrolled conditions, including but not limited to, acute infectious disease, cardiovascular disease, respiratory disease, gastrointestinal disease, liver disease, renal disease, hematology disease, endocrine disorder, psychiatric condition and neurological illness. uncontrolled condition is defined as significant change in therapy or hospitalization for worsening disease during the 3 months before enrollment. have bleeding disorder (e.g. factor deficiency, coagulopathy or platelet disorder), or prior history of significant bleeding or bruising following intramuscular injections or venipuncture. received immunosuppressant or other immunomodulators, antiallergic therapy, or cytotoxicity therapy for 14 or more consecutive days within 6 months before receiving the investigational product (ip). local administration of immunosuppressant or immunomodulator is allowed (e.g., ointment, eye drops, inhalation, or nasal spray). drugs for local administration should not be given at a dose over the recommended level in package insert or participants should have no signs of systemic exposure. administration of immunoglobulin and/or blood product within 3 months before using the ip or plan to use that during the study. continuous use of anticoagulants, such as coumarins and related anticoagulants (i.e., warfarin) or novel oral anticoagulants (i.e., apixaban, rivaroxaban, dabigatran and edoxaban). used other investigational drug or interventional device within 1 month before using the ip or plan to use that during the study, or are using other investigational drug or are within 5 half-lives after the last dose of the investigational drug. used subunit or inactivated vaccine within 14 days before using the ip, or used attenuated live or mrna vaccine within 1 months (30 days) before using the ip, or plan to receive any other vaccines (except for the seasonal influenza vaccine, or emergency use authorized vaccines) during the study. prior receipt of an investigational or licensed covid-19 vaccine, or investigational or approved vaccine against a coronavirus, including but not limited to sars-cov-1 and mers-cov. suspected or known current alcohol or drug dependency. pregnancy, lactation or willingness/intention to become pregnant within 90 days after receiving the last dose of study vaccine. staff of study site, the sponsor, and contract research organization (cro) taking part in study conduct. any other significant disease, disorder or finding which may significantly increase the risk to the volunteer because of participation in the study, affect the ability of the volunteer to participate in the study or impair interpretation of the study data at investigator's discretion.

2

Jiangsu Rec-Biotechnology Co., Ltd.

18

80

Nepal;Russia

Healthy volunteers

N/A

7623

To evaluate the efficacy of ReCOV in preventing Reverse Transcription-Polymerase Chain Reaction (RT-PCR) confirmed symptomatic COVID-19 in adults

None

Phase 3

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