C Reactive Protein Based Early Intervention for Home Quarantined COVID -19 Patients to Avoid Complications and Hospitalization.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 25
- 试验地点
- 1
- 主要终点
- Number of home quarantined COVID -19 positive patients requiring admission in a hospital for hypoxia.
研究概览
简要总结
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
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Mild
Patients with mild symptoms and normal CRP.
干预措施: Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins (Drug)
Moderate
Patients with mild symptoms and less than 10 fold increase in CRP.
干预措施: Oral Antibiotic, Antihistamine, Anti-inflammatory, Multivitamins (Drug)
Moderate
Patients with mild symptoms and less than 10 fold increase in CRP.
干预措施: Oral low dose steroid (Drug)
Moderate
Patients with mild symptoms and less than 10 fold increase in CRP.
干预措施: Oral anti-coagulant (Drug)
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.
干预措施: Intravenous Antibiotics with Low dose steroid. (Drug)
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.
干预措施: Oral anti-coagulant (Drug)
结局指标
主要结局
Number of home quarantined COVID -19 positive patients requiring admission in a hospital for hypoxia.
时间窗: 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.
次要结局
- Number of home quarantined COVID -19 patients developing thromboembolic complications(Four weeks from the time of initial presentation)
研究者
Manimarane Arjunan, MD,DM (Cardiology)
Principal Investigator
UR Anoop Research Group