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Trial - NCT04930770


Column Value
Trial registration number NCT04930770
Full text link
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04930770

First author
Last imported at : March 1, 2023, 9:56 a.m.
Source : ClinicalTrials.gov

Maria Joyera Rodríguez

Contact
Last imported at : March 1, 2023, 9:56 a.m.
Source : ClinicalTrials.gov

Not reported

Registration date
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

2021-06-18

Recruitment status
Last imported at : March 1, 2023, 9:56 a.m.
Source : ClinicalTrials.gov

Withdrawn

Study design
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

nonRCT

Allocation
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

Non-randomized

Design
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

Single group assignment

Masking
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

Open label

Center
Last imported at : July 14, 2021, 6 a.m.
Source : ClinicalTrials.gov

unclear

Study aim
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

Prevention

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

inclusion criteria: age > 18 years; male or female sex; renal transplant with stable renal function in the last 2 months prior to study inclusion. had received a full schedule of vaccination for sars-cov-2 with mrna1273 vaccine (moderna) and remained seronegative at 2 weeks after the second dose. patient giving written informed consent.

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

renal transplantation < 3 months; pregnancy or lactation status; rejection treated within the last 6 months; presence of humoral immunity to sars-cov-2 defined as the presence of specific igm/igg.

Number of arms
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

1

Funding
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

Maria Joyera Rodríguez

Inclusion age min
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

100

Countries
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

None

Type of patients
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

High risk patients

Severity scale
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

N/A

Total sample size
Last imported at : March 1, 2023, 9:56 a.m.
Source : ClinicalTrials.gov

0

primary outcome
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

Number of patients with development of cellular and humoral immunity against SARS-CoV-2

Notes
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

None

Phase
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

Phase 2

Arms
Last imported at : June 22, 2021, 1 a.m.
Source : ClinicalTrials.gov

[{"arm_notes": "Third dose 28 days after 2nd dose", "treatment_id": 824, "treatment_name": "Mrna-1273", "treatment_type": "Rna based vaccine", "pharmacological_treatment": "Vaccine"}]