Follow NCT03305341 - Proof-of-Concept - COVID-19 AP TP Vaccine
Anahtar kelimeler
Öz
Açıklama
- Conducting an initial small, controlled trial to assess for therapeutic vaccine activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19 patients.
- 20 Moderate COVID-19 patients
- Moderate COVID-19
- Positive testing by standard RT-PCR assay or equivalent testing
- Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion
- Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) > 93% on room air at sea level, heart rate ≥ 90 beats per minute
- No clinical signs indicative of Severe or Critical Illness Severity
- Our trial duration will be 4-week duration.
- Each dose of Nucleocapsid-GM-CSF contains a minimum of 50 million autologous CD54+ cells activated with Nucleocapsid-GM-CSF, suspended in 250 mL of Lactated Ringer's Injection, USP.
- Intravenous Injection, IV
- After 60 hours
- Test Macrophage Migration Inhibitory Factor (MMIF)
- If Macrophage Migration Inhibitory Factor (MMIF) is positive (+)
- Successful trained immunity to COVID-19 specific antigen
Tarih
| Son Doğrulandı: | 06/30/2020 |
| İlk Gönderilen: | 11/14/2017 |
| Tahmini Kayıt Gönderildi: | 11/16/2017 |
| İlk Gönderilen: | 11/20/2017 |
| Son Güncelleme Gönderildi: | 07/19/2020 |
| Son Güncelleme Gönderildi: | 07/22/2020 |
| Fiili Çalışma Başlangıç Tarihi: | 07/19/2020 |
| Tahmini Birincil Tamamlanma Tarihi: | 10/09/2020 |
| Tahmini Çalışma Tamamlanma Tarihi: | 11/09/2020 |
Durum veya hastalık
Müdahale / tedavi
Biological: Assess for therapeutic vaccine activity (proof-of-concept)
Evre
Kol Grupları
| Kol | Müdahale / tedavi |
|---|---|
| Experimental: Assess for therapeutic vaccine activity (proof-of-concept) Each dose of Nucleocapsid-GM-CSF contains a minimum of 50 million autologous CD54+ cells activated with Nucleocapsid-GM-CSF, suspended in 250 mL of Lactated Ringer's Injection, USP. | Biological: Assess for therapeutic vaccine activity (proof-of-concept) Intravenous Injection, IV
COVID-19 Nucleocapsid-GM-CSF Protein Lactated Ringer's Injection |
Uygunluk kriterleri
| Çalışmaya Uygun Yaşlar | 22 Years İçin 22 Years |
| Çalışmaya Uygun Cinsiyetler | All |
| Sağlıklı Gönüllüleri Kabul Ediyor | Evet |
| Kriterler | - Conducting an initial small, controlled trial to assess for therapeutic vaccine activity (proof-of-concept) that suggests the potential for clinical benefit of COVID-19 patients. - 20 Moderate COVID-19 patients - - - - Inclusion Criteria: - Moderate COVID-19 - Positive testing by standard RT-PCR assay or equivalent testing - Symptoms of moderate illness with COVID-19, which could include any symptom of mild illness or shortness of breath with exertion - Clinical signs suggestive of moderate illness with COVID-19, such as respiratory rate ≥ 20 breaths per minute, saturation of oxygen (SpO2) > 93% on room air at sea level, heart rate ≥ 90 beats per minute - No clinical signs indicative of Severe or Critical Illness Severity - - - - Exclusion Criteria: - 1. Severe or Critical Illness Severity - 2. Pregnancy - 3. Breast-feeding - 4. The patients with other serious inter-current illness - 5. Serious Allergy - 6. Serious Bleed Tendency - 7. The prohibition of the biological product |
Sonuç
Birincil Sonuç Ölçütleri
1. Test Macrophage Migration Inhibitory Factor (MMIF) [28 days]
