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

NCT ID: NCT04935515

Last Updated: 2021-06-23

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-15

Study Completion Date

2021-06-06

Brief Summary

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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

Detailed Description

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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.

Conditions

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COVID -19

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Study Groups

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Mild

Patients with mild symptoms and normal CRP.

Group Type EXPERIMENTAL

Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins

Intervention Type DRUG

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

Moderate

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

Group Type EXPERIMENTAL

Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins

Intervention Type DRUG

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

Oral low dose steroid

Intervention Type DRUG

Low dose oral methyl prednisolone was added.

Oral anti-coagulant

Intervention Type DRUG

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

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.

Group Type EXPERIMENTAL

Intravenous Antibiotics with Low dose steroid.

Intervention Type DRUG

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

Oral anti-coagulant

Intervention Type DRUG

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

Interventions

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Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins

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

Intervention Type DRUG

Oral low dose steroid

Low dose oral methyl prednisolone was added.

Intervention Type DRUG

Intravenous Antibiotics with Low dose steroid.

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

Intervention Type DRUG

Oral anti-coagulant

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UR Anoop Research Group

OTHER

Sponsor Role collaborator

Manimarane Arjunan, MD,DM (Cardiology)

OTHER

Sponsor Role lead

Responsible Party

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Manimarane Arjunan, MD,DM (Cardiology)

Principal Investigator

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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MANIMARANE ARJUNAN, MD,DM-CARDIO

Role: PRINCIPAL_INVESTIGATOR

UR Anoop Research Group

Locations

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ONLINE

Puducherry, , India

Site Status

Countries

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India

Other Identifiers

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1/MA/URA/21

Identifier Type: -

Identifier Source: org_study_id

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