C Reactive Protein in Home Quarantined Coronavirus Disease 2019 (COVID -19) Patients.

NCT04935515 | Completed

• 1 other identifier: 1/MA/URA/21
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

During the peak of the second COVID -19 wave, the hospitals were over-crowded. Many COVID -19 positive patients had to stay at home and reach out to their family physicians for guidance. Medical follow-up for these patients was a daunting challenge. As in - patient hospital facilities were not readily accessible due to over crowding, early objective tests to identify home quarantined patients prone to deterioration and timely medical intervention to avoid hospitalization were required. Based on early assessment of inflammatory markers like CRP and clinical signs like persistent high-grade fever, need-based early medical intervention was initiated in home quarantined COVID -19 patients prior to the onset of hypoxia, in order to avoid complications and hospitalization

Conditions

COVID -19

Keywords

COVID -19;; Home quarantine;; C-Reactive Protein (CRP);; D-Dimer,; Early Intervention prior to onset of hypoxia

Outcome Measures

Primary Outcomes (1)

• Number of home quarantined COVID -19 positive patients requiring admission in a hospital for hypoxia.

  Oxygen saturation in COVID-19 positive patients was monitored using pulse oximetry at home. Those patients who developed hypoxia (less than 94%) were referred for hospitalization.

  Two weeks from the onset of symptoms.

Secondary Outcomes (1)

• Number of home quarantined COVID -19 patients developing thromboembolic complications

  Four weeks from the time of initial presentation

Study Arms (3)

Mild

EXPERIMENTAL

Patients with mild symptoms and normal CRP.

Drug: Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins

Moderate

EXPERIMENTAL

Patients with mild symptoms and less than 10 fold increase in CRP.

Drug: Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins; Drug: Oral low dose steroid; Drug: Oral anti-coagulant

Severe

EXPERIMENTAL

Patients with high grade fever persisting even on the third or fourth day after onset of symptoms or 10 fold or more increase in CRP.

Drug: Intravenous Antibiotics with Low dose steroid.; Drug: Oral anti-coagulant

Interventions

Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins DRUG

Oral Azithromycin , Cetirizine, Paracetamol, Zinc, Vitamin C, Vitamin D

Mild; Moderate

Oral low dose steroid DRUG

Low dose oral methyl prednisolone was added.

Moderate

Intravenous Antibiotics with Low dose steroid. DRUG

Intravenous ceftriaxone with either oral methyl prednisolone or intravenous dexamethasone was given

Severe

Oral anti-coagulant DRUG

Rivaroxaban was given for minimum 4 weeks depending on D dimer levels

Moderate; Severe

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• COVID -19 positive patients under home quarantine
• Patients consulting online on the 3rd or 4th day after the onset of symptoms.
• Patients with oxygen saturation 94% and above.

You may not qualify if:

• Patients consulting online on or after 5th day of onset of symptoms.
• Patients with oxygen saturation less than 94% during the initial presentation.
• Systemic disease known to increase CRP levels.

Sponsors & Collaborators

• Manimarane Arjunan, MD,DM (Cardiology): lead
• UR Anoop Research Group: collaborator

Study Sites (1)

ONLINE

Puducherry, India

Location

MeSH Terms

Conditions

COVID-19

Interventions

Anti-Bacterial Agents; Histamine Antagonists; Anti-Inflammatory Agents; Geritol; Steroids; Anticoagulants

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)

Anti-Infective Agents; Therapeutic Uses; Pharmacologic Actions; Chemical Actions and Uses; Histamine Agents; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Physiological Effects of Drugs; Fused-Ring Compounds; Polycyclic Compounds; Hematologic Agents

Study Officials

• MANIMARANE ARJUNAN, MD,DM-CARDIO

  UR Anoop Research Group

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 20, 2021
• First Posted: June 23, 2021
• Study Start: April 15, 2021
• Primary Completion: May 9, 2021
• Study Completion: June 6, 2021
• Last Updated: June 23, 2021

Record last verified: 2021-06

Data Sharing

• IPD Sharing: Will not share

Locations

IN (1)