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

C Reactive Protein Based Early Intervention for Home Quarantined COVID -19 Patients to Avoid Complications and Hospitalization.

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

Study Overview

• Status: Completed
• Conditions: COVID -19
• Intervention / Treatment: Drug: Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins; Drug: Oral low dose steroid; Drug: Oral anti-coagulant; Drug: Intravenous Antibiotics with Low dose steroid.

Detailed Description

25 home quarantined COVID -19 patients who contacted online for medical guidance underwent clinical and biochemical evaluation. Radiological evaluation was done only if indicated.

Based on early objective biochemical tests like elevated CRP and clinical signs like persistent high-grade fever on the third or fourth day after onset of symptoms, early medical treatment was initiated prior to onset of hypoxia.

All the 25 patients recovered without any complications and did not require hospitalization.

• Study Type: Interventional
• Enrollment (Actual): 25
• Phase: Not Applicable

Contacts and Locations

Study Locations

• India
  • Puducherry, India
    • Online

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Mild; Patients with mild symptoms and normal CRP.	Drug: Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins; Oral Azithromycin , Cetirizine, Paracetamol, Zinc, Vitamin C, Vitamin D
Experimental: Moderate; Patients with mild symptoms and less than 10 fold increase in CRP.	Drug: Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins; Oral Azithromycin , Cetirizine, Paracetamol, Zinc, Vitamin C, Vitamin D; Drug: Oral low dose steroid; Low dose oral methyl prednisolone was added.; Drug: Oral anti-coagulant; Rivaroxaban was given for minimum 4 weeks depending on D dimer levels
Experimental: Severe; 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: Oral anti-coagulant; Rivaroxaban was given for minimum 4 weeks depending on D dimer levels; Drug: Intravenous Antibiotics with Low dose steroid.; Intravenous ceftriaxone with either oral methyl prednisolone or intravenous dexamethasone was given

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of home quarantined COVID -19 patients developing thromboembolic complications	Thromboembolic complications in COVID-19 positive patients under home quarantine were assessed using an online questionnaire.	Four weeks from the time of initial presentation

Collaborators and Investigators

• Sponsor: Manimarane Arjunan, MD,DM (Cardiology)
• Collaborators: UR Anoop Research Group
• Investigators: Principal Investigator: MANIMARANE ARJUNAN, MD,DM-CARDIO, UR Anoop Research Group

Study record dates

Study Major Dates

• Study Start (Actual): April 15, 2021
• Primary Completion (Actual): May 9, 2021
• Study Completion (Actual): June 6, 2021

Study Registration Dates

• First Submitted: June 20, 2021
• First Submitted That Met QC Criteria: June 22, 2021
• First Posted (Actual): June 23, 2021

Study Record Updates

• Last Update Posted (Actual): June 23, 2021
• Last Update Submitted That Met QC Criteria: June 22, 2021
• Last Verified: June 1, 2021

More Information

Terms related to this study

• Keywords: COVID -19;; Home quarantine;; C-Reactive Protein (CRP);; D-Dimer,; Early Intervention prior to onset of hypoxia
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Neurotransmitter Agents; Molecular Mechanisms of Pharmacological Action; Anti-Infective Agents; Antitubercular Agents; Histamine Agents; Anti-Inflammatory Agents; Anti-Bacterial Agents; Antibiotics, Antitubercular; Histamine H1 Antagonists; Histamine Antagonists; Anticoagulants; Coagulants
• Other Study ID Numbers: 1/MA/URA/21

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No