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Trial - NCT04690387


Column Value
Trial registration number NCT04690387
Full text link
Last imported at : Jan. 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04690387

First author
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Muhammad Karayana, MD, MPH

Contact
Last imported at : Jan. 29, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

mkaryana@gmail.com

Registration date
Last imported at : Jan. 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

2020-12-30

Recruitment status
Last imported at : April 6, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Completed

Study design
Last imported at : Jan. 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Jan. 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Jan. 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Adaptive

Masking
Last imported at : Jan. 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : March 15, 2023, 4 a.m.
Source : ClinicalTrials.gov

single-center

Study aim
Last imported at : Jan. 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Jan. 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

inclusion criteria: - 18 years or older, relatively good health, negative for pre-existing sars-cov-2 antibodies, negative for sars-cov-2 infection

Exclusion criteria
Last imported at : Jan. 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

- active covid-19 infection by pcr testing, pre-existing sars-cov-2 antibodies, pregnant, known hypersensitivity to gm-csf, known immune deficiency disease, on active treatment with immunosuppressive agent or corticosteroid, participated in previous covid-19 trial

Number of arms
Last imported at : Jan. 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

9

Funding
Last imported at : Jan. 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Aivita Biomedical, Inc.

Inclusion age min
Last imported at : Jan. 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Jan. 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : Jan. 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Indonesia

Type of patients
Last imported at : Jan. 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : Jan. 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : Jan. 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

27

primary outcome
Last imported at : Jan. 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

Incidence and severity of adverse events (safety)

Notes
Last imported at : Jan. 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : Feb. 25, 2021, 7:58 p.m.
Source : ClinicalTrials.gov

Phase 1

Arms
Last imported at : Jan. 1, 2021, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "0.1 mg antigen, 0 mcg GMCSF;1", "treatment_id": 1745, "treatment_name": "Av-covid-19", "treatment_type": "Viral vector (non-replicating)/apc (antigen presenting cell)", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "0.33 mg antigen, 0 mcg GM-CSF;1", "treatment_id": 1745, "treatment_name": "Av-covid-19", "treatment_type": "Viral vector (non-replicating)/apc (antigen presenting cell)", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1.0 mg antigen, 0 mcg GMCSF;1", "treatment_id": 1745, "treatment_name": "Av-covid-19", "treatment_type": "Viral vector (non-replicating)/apc (antigen presenting cell)", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "0.1 mg antigen, 250 mcg GM-CSF;1", "treatment_id": 1745, "treatment_name": "Av-covid-19", "treatment_type": "Viral vector (non-replicating)/apc (antigen presenting cell)", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "0.33 mg antigen, 250 mcg GM-CSF;1", "treatment_id": 1745, "treatment_name": "Av-covid-19", "treatment_type": "Viral vector (non-replicating)/apc (antigen presenting cell)", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1.0 mg antigen, 250 mcg GM-CSF;1", "treatment_id": 1745, "treatment_name": "Av-covid-19", "treatment_type": "Viral vector (non-replicating)/apc (antigen presenting cell)", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "0.1 mg antigen, 500 mcg GM-CSF;1", "treatment_id": 1745, "treatment_name": "Av-covid-19", "treatment_type": "Viral vector (non-replicating)/apc (antigen presenting cell)", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "0.33 mg antigen, 500 mcg GM-CSF;1", "treatment_id": 1745, "treatment_name": "Av-covid-19", "treatment_type": "Viral vector (non-replicating)/apc (antigen presenting cell)", "pharmacological_treatment": "Vaccine"}, {"arm_notes": "1.0 mg antigen, 500 mcg GM-CSF;1", "treatment_id": 1745, "treatment_name": "Av-covid-19", "treatment_type": "Viral vector (non-replicating)/apc (antigen presenting cell)", "pharmacological_treatment": "Vaccine"}]