COVID-19 trials registries data warehouse

 Return to trial list

Trial - NCT04639375


Column Value
Trial registration number NCT04639375
Full text link
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

First author
Last imported at : Aug. 28, 2021, 8 p.m.
Source : ClinicalTrials.gov

John Andrews, PhD

Contact
Last imported at : Aug. 28, 2021, 8 p.m.
Source : ClinicalTrials.gov

johnclaytonandrews@gmail.com

Registration date
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

2020-11-20

Recruitment status
Last imported at : Aug. 28, 2021, 8 p.m.
Source : ClinicalTrials.gov

Not recruiting

Study design
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

nonRCT

Allocation
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Non-randomized

Design
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Single group assignment

Masking
Last imported at : Nov. 23, 2020, 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 : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Prevention

Inclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

inclusion criteria: provision of signed and dated informed consent form stated willingness to comply with all study procedures and availability for the duration of the study male or female, aged 18-80 female subjects of child-bearing potential must have a negative pregnancy test (point-of-care dipstick) prior to being vaccinated and be willing to use an effective method of birth control from the time of entry into the study and for 30 days following vaccination in good general health with no active infectious disease as evidenced by medical history and directed physical examination.

Exclusion criteria
Last imported at : Nov. 16, 2021, 6:30 p.m.
Source : ClinicalTrials.gov

known allergic reactions to components of the polio vaccine febrile illness within 14 days positive for sars-cov-2 antigenemia at any time prior to screening1 positive for sars-cov-2 antibodies at any time prior to screening1 subjects with fever > 101o f at screening subjects who respond yes to any of the following question: have you experienced any of the following symptoms in the past 48 hours (14): fever or chills cough shortness of breath or difficulty breathing fatigue muscle or body aches headache new loss of taste or smell sore throat congestion or runny nose nausea or vomiting diarrhea treatment with an investigational drug or other intervention within the 90 days prior to enrollment in this study inoculation with polio vaccine within the last 12 years women who are pregnant or breast feeding

Number of arms
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

1

Funding
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

E-MO Biology Inc

Inclusion age min
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

80

Countries
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

United States

Type of patients
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Healthy volunteers

Severity scale
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

N/A

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

300

primary outcome
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

Percentage of Subjects with Antibodies to SARS-CoV-2 RdRp following IPV Vaccination

Notes
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

None

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

Phase 4

Arms
Last imported at : Nov. 23, 2020, 12:31 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "1", "treatment_id": 1007, "treatment_name": "Polio vaccine", "treatment_type": "Non covid vaccine", "pharmacological_treatment": "Non covid vaccine"}]