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Trial - NCT04987554


Column Value
Trial registration number NCT04987554
Full text link
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov

https://clinicaltrials.gov/show/NCT04987554

First author
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov

Diego Fernández, Professor PhD

Contact
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov

diego.fernandez.lazaro@uva.es

Registration date
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov

2021-08-03

Recruitment status
Last imported at : July 6, 2023, midnight
Source : ClinicalTrials.gov

Unknown

Study design
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov

RCT

Allocation
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov

Randomized

Design
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov

Parallel

Masking
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov

Blind label

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

single-center

Study aim
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov

Treatment

Inclusion criteria
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov

inclusion criteria: - ≥18 years - males and females - confirmed clinical diagnosis of covid-19 positive by real-time reverse transcription polymerase chain reaction (rt-pcr) and/or sars-cov-2 antigen test performed 120 hours prior to patient inclusion in the study - ldh 250-400 u/l - acceptance of informed consent signature - imc: 18.5-30 - patients not participating in other trials - no hepatic and renal disorders - possession of mental faculties to participate in the study

Exclusion criteria
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov

- patients with rare and specific viral diseases such as hiv - patients undergoing chemotherapy during the last 2 months - any other condition/pathology diagnosed by the medical specialist that prevents them from participating in the trial - intake of vitamin complexes or functional foods

Number of arms
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov

2

Funding
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov

University of Valladolid

Inclusion age min
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov

18

Inclusion age max
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov

80

Countries
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov

Spain

Type of patients
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov

Severe disease at enrollment

Severity scale
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov

6: Severe disease at enrollment

Total sample size
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov

120

primary outcome
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov

Lactato deshidrogenasa (LDH);Lactato deshidrogenasa (LDH)

Notes
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov

None

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

Not reported

Arms
Last imported at : Aug. 4, 2021, 2 p.m.
Source : ClinicalTrials.gov

[{"arm_notes": "", "treatment_id": 2326, "treatment_name": "Glycophosphopeptical am3", "treatment_type": "Nutrition", "pharmacological_treatment": "Non pharmacological treatment"}, {"arm_notes": "", "treatment_id": 2187, "treatment_name": "Placebo", "treatment_type": "Placebo", "pharmacological_treatment": "Placebo"}]