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Completed

NCT Number: NCT04935515

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

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

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Key information

Conditions

COVID -19 COVID-19 Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ONLINE

Puducherry, India

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins

Drug

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

Oral low dose steroid

Drug

Low dose oral methyl prednisolone was added.

Intravenous Antibiotics with Low dose steroid.

Drug

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

Oral anti-coagulant

Drug

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

Primary outcomes

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

    Time frame: Two weeks from the onset of symptoms.

    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.

Secondary outcomes

  1. Number of home quarantined COVID -19 patients developing thromboembolic complications

    Time frame: Four weeks from the time of initial presentation

    Thromboembolic complications in COVID-19 positive patients under home quarantine were assessed using an online questionnaire.

Sponsors and collaborators

Lead sponsor

Manimarane Arjunan, MD,DM (Cardiology)

Other

Collaborators

  • UR Anoop Research Group

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2021
Study completion
2021
First posted
Jun 23, 2021
Registry last updated
Jun 23, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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