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The main aim is to determine whether vitamin C can reduce 28-day all-cause mortality or persistent organ dysfunction compared with placebo in patients with severe and critical ill COVID-19 patients.
Participants will randomly receive HIVC or placebo for 4 days once enrolled. The primary outcome is a composite of death or persistent organ dysfunction (defined as dependency on vasopressors, mechanical ventilation, or CRRT) at day 28 after randomization.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vitamin C | Experimental | 12 g Vitamin C will be infused within 6 hours by an infusion pump. This treatment will be repeated every 12 hours for 4 days. |
|
| Placebo | Placebo Comparator | The control group is assigned a placebo (5% glucose). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Vitamin C | Drug | The total dosage of vitamin C for the treatment group is 24 g per day. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| The 28-day mortality or persistent organ dysfunctionat day 28. | Persistent organ dysfunction was defined as dependency on vasopressors, mechanical ventilation, or new and persisting RRT. | 28 days. |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the Sepsis-Related Organ Failure Assessment (SOFA) score. | The SOFA score range from 0 (mild) to 24 (critical ill). Change = (Day 4 score - Baseline score) | 4 days. |
| Change in Plasma Inflammatory Biomarker Concentrations. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Liu Zhanguo, MD,PhD | Contact | 18520711669 | zhguoliu@163.com | |
| Yu Shuang, MD | Contact | 13476932240 | yushuang7991@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Liu Zhanguo, MD,PhD | Southern Medical University, China | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Critical Care Medicine of Zhujiang Hospital | Recruiting | Guanzhou | Guangdong | China |
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| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| ID | Term |
|---|---|
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D001205 | Ascorbic Acid |
| ID | Term |
|---|---|
| D013400 | Sugar Acids |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D009930 | Organic Chemicals |
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A prospective, multi-center, randomized, single-blind, placebo-controlled clinical trial
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| Placebo |
| Drug |
The total dosage of placebo(5% glucose) for the control group is 24 g per day. |
|
| 4 days. |
| Changes in oxygenation index and partial pressure of carbon dioxide in arterial blood gases. | 4 days. |
| The duration of ventilation and vasopressor use. | 28 days. |
| The length of ICU stay and hospital stay. | 28 days. |
| Yunfu People's Hospital | Recruiting | Yunfu | Guangdong | China |
|
| Department of Critical Care Medicine of Zhongshan People's Hospital | Not yet recruiting | Zhongshan | Guangzhou | 528403 | China |
|
| the Affiliated Nanhua Hospital | Recruiting | Hengyang | Hunan | China |
|
| D014777 |
| Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D006880 |
| Hydroxy Acids |
| D002241 | Carbohydrates |