Effect Of Calcitriol On Neutrophil To Lymphocytes Ratio And High Sensitivity C-Reactive Protein Covid-19 Patients

NCT05765617 | Completed Phase 2 DMC

• 1 other identifier: NAP03
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

This research is a study that compares the administration of calcitriol with the outcomes of COVID-19 patients

Conditions

COVID-19

Keywords

calcitriol, HsCRP

Outcome Measures

Primary Outcomes (1)

• HsCRP

  High-sensitivity C-reactive protein (hsCRP) is a marker of inflammation

  Hs CRP (high sensitive c reactive protein) examination was carried out on the first day of hospitalization and the 5th day of hospitalization

Study Arms (2)

Control

PLACEBO COMPARATOR

Placebo 2x1 per day

Other: Placebo

Calcitriol

EXPERIMENTAL

the treatment group received calcitriol 2x400 iu per day for 5 day

Drug: Calcitriol

Interventions

Calcitriol DRUG

The treatment group received calcitriol 2x400 iu per day for five days. Calcitriol uses Oscal, obtained from Kalbe Pharma

Also known as: Oscal

Calcitriol

Placebo OTHER

Placebo give 2x1 per day for five day

Control

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• COVID-19 patients, hospitalized patients, and patients aged 18-60 years

You may not qualify if:

• pregnancy

Sponsors & Collaborators

• Universitas Sebelas Maret: lead

Study Sites (1)

Universitas Sebelas Maret Hospital

Sukoharjo, Central Java, 57161, Indonesia

Location

MeSH Terms

Conditions

COVID-19

Interventions

Calcitriol

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Dihydroxycholecalciferols; Hydroxycholecalciferols; Cholecalciferol; Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Officials

• Nurhasan Agung Prabowo, MD

  Universitas Sebelas Maret

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This study used calcitriol and a placebo, which were similar in shape; researchers and patients did not know who was getting the drug or placebo.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: M.D.

Model Details: This research was an observational analytic cohort retrospective study in which the subjects were moderate degree COVID-19 inpatients in Sebelas Maret University Hospital divided into two groups. The control group received standard therapy, while the treatment group received calcitriol 2x400 iu per day.

Study Record Dates

• First Submitted: March 9, 2023
• First Posted: March 13, 2023
• Study Start: July 1, 2021
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: March 13, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)